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Theraflu Expressmax Daytime Severe Cold and Cough and Theraflu Expressmax Nighttime Severe Cold and Cough

Dosage form: kit
Ingredients: ACETAMINOPHEN 325mg, DEXTROMETHORPHAN HYDROBROMIDE 10mg, PHENYLEPHRINE HYDROCHLORIDE 5mg; ACETAMINOPHEN 325mg, DIPHENHYDRAMINE HYDROCHLORIDE 12.5mg, PHENYLEPHRINE HYDROCHLORIDE 5mg
Labeler: GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
NDC Code: 0067-8138

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Facts

Theraflu® ExpressMax™ Daytime Severe Cold & Cough

[Enter Generic Section here]

Active ingredients (in each caplet)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg

Purposes

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

Uses
temporarily relieves these symptoms due to a cold:
o
minor aches and pains
o
minor sore throat pain
o
headache
o
nasal and sinus congestion
o
cough due to minor throat and bronchial irritation
temporarily reduces fever

Warnings

Liver warning: This product contains acetaminophen. Severe lever damage may occur if you take

more than 4,000 mg of acetaminophen in 24 hours
with other drugs containing acetaminophen
3 or more alcoholic drinks every day while using this product

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

skin reddening
blisters
rash

If a skin reaction occurs, stop use and seek medical help right away.

Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting consult a doctor promptly.

Do not use
in a child under 12 years of age
if you are allergic to acetaminophen
with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have
liver disease
heart disease
high blood pressure
thyroid disease
diabetes
trouble urinating due to an enlarged prostate gland
cough that occurs with too much phlegm (mucus)
cough that lasts or is chronic such as occurs with smoking, asthma or emphysema

Ask a doctor or pharmacist before use if you are
taking the blood thinning drug warfarin

When using this product
do not exceed recommended dosage

Stop use and ask a doctor if
nervousness, dizziness, or sleeplessness occurs
fever gets worse or lasts more than 3 days
redness or swelling is present
new symptoms occur
pain, cough or nasal congestion gets worse or lasts more than 7 days
cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions
do not use more than directed
adults and children 12 years of age and over: take 2 caplets every 4 hours, while symptoms persist. Do not take more than 10 caplets in 24 hours unless directed by a doctor
children under 12 years of age: do not use

Other information

store at controlled room temperature 20-25°C (68-77°F)

Inactive ingredients

benzoic acid, carmine, croscarmellose sodium, ethanol, ferric oxide yellow, flavors, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polysorbate 60, polysorbate 80, povidone, pregelatinized starch, propylene glycol, silicon dioxide, stearic acid, sucralose, titanium dioxide

Questions or Comments?

call 1-800-452-0051

Theraflu® ExpressMax™ Nighttime Severe Cold & Cough

[Enter Generic Section here]

Active ingredients (in each caplet)

Acetaminophen 325 mg

Diphenhydramine HCl 12.5 mg

Phenylephrine HCl 5 mg

Purposes

Pain reliever/fever reducer

Antihistamine/cough suppressant

Nasal decongestant

Uses
temporarily relieves these symptoms due to a cold:
o
minor aches and pains
o
minor sore throat pain
o
headache
o
nasal and sinus congestion
o
runny nose
o
sneezing
o
itchy nose or throat
o
itchy, watery eyes due to hay fever
o
cough due to minor throat and bronchial irriation
temporarily reduces fever

Warnings

Liver warning: This product contains acetaminophen. Severe lever damage may occur if you take

more than 4,000 mg of acetaminophen in 24 hours
with other drugs containing acetaminophen
3 or more alcoholic drinks every day while using this product

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

skin reddening
blisters
rash

If a skin reaction occurs, stop use and seek medical help right away.

Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting consult a doctor promptly.

Do Not Use
in a child under 12 years of age
if you are allergic to acetaminophen
with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
with any product containing diphenhydramine, even one used on the skin
if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have
liver disease
heart disease
high blood pressure
thyroid disease
diabetes
glaucoma
trouble urinating due to an enlarged prostate gland
a breathing problem such as emphysema or chronic bronchitis
cough that occurs with too much phlegm (mucus)
cough that lasts or is chronic such as occurs with smoking, asthma or emphysema

Ask a doctor or pharmacist before use if you are
taking sedatives or tranquilizers
taking the blood thinning drug warfarin

When using this product
do not exceed recommended dosage
avoid alcoholic drinks
marked drowsiness may occur
alcohol, sedatives and tranquilizers may increase drowsiness
be careful when driving a motor vehicle or operation machinery
excitability may occur, especially in children

Stop use and ask a doctor if
nervousness, dizziness, or sleeplessness occurs
fever gets worse or lasts more than 3 days
redness or swelling is present
new symptoms occur
pain, cough or nasal congestion gets worse or lasts more than 7 days
cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions
do not use more than directed
adults and children 12 years of age and over: take 2 caplets every 4 hours, while symptoms persist. Do not take more than 10 caplets in 24 hours unless directed by a doctor
children under 12 years of age: do not use

Other information
store at controlled room temperature 20-25°C (68-77°F)

Inactive ingredients

Benzoic acid, croscarmellose sodium, ethanol, FD&C blue no.2 aluminum lake, ferrosoferric oxide, flavors, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polysorbate 60, polysorbate 80, povidone, pregelatinized starch, propylene glycol, silicone dioxide, stearic acid, sucralose, titanium dioxide

Questions or Comments?

call 1-800-452-0051

Principal Display Panel

NDC 0067-8138-40

Theraflu® Express Max™

VALUE PACK

WARMING RELIEF™ FORMULA

DAYTIME NIGHTTIME

SEVERE COLD & COUGH

ACETAMINOPHEN – PAIN RELIEVER/FEVER REDUCER

DEXTROMETHORPHAN HBr – COUGH SUPPRESSANT

PHENYLEPHRINE HCl – NASAL DECONGESTANT

NASAL CONGESTION • SORE THROAT
HEADACHE • BODY ACHE • COUGH • FEVER

20 COATED CAPLETS

ACETAMINOPHEN – PAIN RELIEVER/FEVER REDUCER

DIPHENHYDRAMINE HCl – ANTIHISTAMINE/COUGH SUPPRESSANT

PHENYLEPHRINE HCl – NASAL DECONGESTANT

NASAL CONGESTION • SORE THROAT • FEVER • BODY ACHE
RUNNY NOSE • HEADACHE • COUGH

DO NOT TAKE BOTH PRODUCTS AT THE SAME TIME OR TAKE MORE THAN 5 DOSES IN TOTAL IN ANY 24 HOUR PERIOD.

PARENTS:

Learn about teen medicine abuse

www.StopMedicineAbuse.org

TAMPER EVIDENT FEATURE:

THERAFLU® EXPRESSMAX CAPLETS ARE SEALED IN BLISTER PACKETS. USE ONLY IF THE INDIVIDUAL SEAL IS UNBROKEN.

DO NOT TAKE A DOSE OF THE NIGHTTIME PRODUCT SOONER THAN 4 HOURS AFTER THE LAST DOSE OF THE DAYTIME PRODUCT UNLESS DIRECTED BY YOUR DOCTOR.

Distributed by: GSK Consumer Healthcare, Warren, NJ 07059

Trademarks are owned by or licensed to the GSK group of companies.

©2016 GSK group of companies or its licensor. All rights reserved.

www.theraflu.com

12540

THERAFLU EXPRESSMAX DAYTIME SEVERE COLD AND COUGH AND THERAFLU EXPRESSMAX NIGHTTIME SEVERE COLD AND COUGH 
acetaminophen, dextromethorphan hbr, phenylephrine hcl, diphenhydramine hcl kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0067-8138
Packaging
#Item CodePackage Description
1NDC:0067-8138-401 KIT in 1 CARTON
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 12 BLISTER PACK 20 
Part 22 BLISTER PACK 20 
Part 1 of 2
THERAFLU EXPRESSMAX DAYTIME SEVERE COLD AND COUGH 
acetaminophen, dextromethorphan hbr, phenylephrine tablet, film coated
Product Information
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN325 mg
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE10 mg
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
BENZOIC ACID 
CROSCARMELLOSE SODIUM 
ALCOHOL 
FERRIC OXIDE YELLOW 
HYPROMELLOSES 
MAGNESIUM STEARATE 
MALTODEXTRIN 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOLS 
POLYSORBATE 60 
POLYSORBATE 80 
POVIDONES 
STARCH, CORN 
PROPYLENE GLYCOL 
SILICON DIOXIDE 
STEARIC ACID 
SUCRALOSE 
TITANIUM DIOXIDE 
Product Characteristics
ColorREDScoreno score
ShapeOVAL (caplet) Size18mm
FlavorMINTImprint Code1143D
Contains    
Packaging
#Item CodePackage Description
12 BLISTER PACK in 1 CARTON
110 TABLET, FILM COATED in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34107/05/2016
Part 2 of 2
THERAFLU EXPRESSMAX NIGHTTIME SEVERE COLD AND COUGH 
acetaminophen, diphenhydramine hcl, phenylephrine hcl tablet, film coated
Product Information
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN325 mg
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE12.5 mg
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
BENZOIC ACID 
CROSCARMELLOSE SODIUM 
ALCOHOL 
FD&C BLUE NO. 2 
ALUMINUM OXIDE 
FERROSOFERRIC OXIDE 
HYPROMELLOSES 
MAGNESIUM STEARATE 
MALTODEXTRIN 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOLS 
POLYSORBATE 60 
POLYSORBATE 80 
POVIDONES 
STARCH, CORN 
PROPYLENE GLYCOL 
SILICON DIOXIDE 
STEARIC ACID 
SUCRALOSE 
TITANIUM DIOXIDE 
Product Characteristics
ColorBLUEScoreno score
ShapeOVAL (caplet) Size18mm
FlavorMINTImprint Code1143N
Contains    
Packaging
#Item CodePackage Description
12 BLISTER PACK in 1 CARTON
110 TABLET, FILM COATED in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34107/05/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34107/05/2016
Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)

 
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC

Medically reviewed on Jul 2, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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