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daytime severe cold and cough and nighttime severe cold and cough

Medically reviewed on Jan 18, 2018

Dosage form: kit
Ingredients: ACETAMINOPHEN 650mg, DEXTROMETHORPHAN HYDROBROMIDE 20mg, PHENYLEPHRINE HYDROCHLORIDE 10mg; ACETAMINOPHEN 650mg, DIPHENHYDRAMINE HYDROCHLORIDE 25mg, PHENYLEPHRINE HYDROCHLORIDE 10mg
Labeler: Target Corporation
NDC Code: 11673-542

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.

daytime severe cold and cough & nighttime severe cold and cough value pack

Active ingredients (in each packet) – Daytime Severe Cold and Cough

Acetaminophen 650 mg

Dextromethorphan HBr 20 mg

Phenylephrine HCl 10 mg

Active ingredients (in each packet) - Nighttime Severe Cold and Cough

Acetaminophen 650 mg

Diphenhydramine HCl 25 mg

Phenylephrine HCl 10 mg

Purposes - Daytime Severe Cold and Cough

Pain reliever/fever reducer

Cough Suppressant

Nasal Decongestant

Purpose - Nighttime Severe Cold and Cough

Pain reliever/fever reducer

Antihistamine/cough Suppressant

Nasal Decongestant

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

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

Warnings – Daytime Severe Cold and Cough and Nighttime Severe Cold and Cough

Liver warning: This product contains acetaminophen. Severe liver 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

Is 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 - Daytime Severe Cold and Cough
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 a 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.

Do not use - Nighttime Severe Cold and Cough
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 a pharmacist.
with any other product containing diphenhydramine, even one used on 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 a MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have - Daytime Severe Cold and Cough
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 before use if you have - Nighttime Severe Cold and Cough
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 - Daytime Severe Cold and Cough

taking the blood thinning drug warfarin

Ask a doctor or pharmacist before use if you are - Nighttime Severe Cold and Cough
taking sedatives or tranquilizers
taking the blood thinning drug warfarin

When using this product - Daytime Severe Cold and Cough

do not exceed recommended dosage

When using this product - Nighttime Severe Cold and Cough
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 operating machinery
excitability may occur, especially in children

Stop use and ask a doctor if – Daytime Severe Cold and Cough /Nighttime Severe Cold and Cough
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 (1-800-222-1222). Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions – Daytime Severe Cold and Cough
do not use more than directed
take every 4 hours, while symptoms persist, Do not take more than 5 packets in 24 hours unless directed by a doctor

Age

Dose

Adults and children 12 years of age and over

One packet

Children under 12 years of age

Do not use

dissolve contents of one packet into 8 oz. hot water: sip while hot. Consume entire drink within 10-15 minutes.
if using a microwave, add contents of one packet to 8 oz. of cool water: stir briskly before and after heating. Do not overheat

Directions Nighttime Severe Cold and Cough
do not use more than directed
take every 4 hours, while symptoms persist, Do not take more than 5 packets in 24 hours unless directed by a doctor.

Age

Dose

Adults and children 12 years of age and over

One packet

Children under 12 years of age

Do not use

dissolve contents of one packet into 8 oz. hot water: sip while hot. Consume entire drink within 10-15 minutes.
if using a microwave, add contents of one packet to 8 oz. of cool water: stir briskly before and after heating. Do not overheat

Other information - Daytime Severe Cold and Cough
each packet contains: potassium 6 mg
store at room temperature. Protect from excessive heat and moisture

Other information - Nighttime Severe Cold and Cough
each packet contains: potassium 6 mg
store at room temperature. Protect from excessive heat and moisture

Inactive ingredients - Daytime Severe Cold and Cough

citric acid ,FD&C blue#1, FD&C red 40#, flavors, maltodextrin, potassium chloride, silica, sucralose, sucrose

Inactive ingredients - Nighttime Severe Cold and Cough

citric acid, FD & C yellow #6, flavors, maltodextrin, potassium chloride, silica ,sucralose, sucrose,

Questions or comments?

1-866-467-2748

Package/Label Principal Display Panel

Compare to active ingredients in Theraflu® Daytime Severe Cold and Cough and Nighttime Severe Cold & Cough*

Value pack

daytime severe cold and cough

acetaminophen(pain reliever/ fever reducer)

dextromethorphan HBr ( cough suppressant)

phenylephrine HCl ( nasal decongestant)

aspartame free, sodium free

relief of nasal and sinus congestion,, cough ,body ache, sore throat pain, headache ,fever

berry flavor

infused with menthol and green tea flavors

6 PACKETS

nighttime severe cold and cough

acetaminophen –(pain reliever/ fever reducer)

diphenhydramine HCl – (antihistamine/ cough suppressant)

phenylephrine HCl – (nasal decongestant)

aspartame free, sodium free

relief of nasal congestion,, cough ,runny nose, sneezing, body ache, sore throat pain, headache ,fever

honey lemon flavor infused with chamomile & white tea flavors

6 PACKETS

READ ALL WARNINGS AND DIRECTIONS ON CARTON BEFORE USE .KEEP CARTON FOR REFERENCE, DO NOT DISCARD.

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

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

*These Products are not manufactured or distributed by GSK Consumer Healthcare, distributor of Theraflu Daytime Severe Cold & Cough and Theraflu Nighttime severe Cold & Cough

Distributed by: Target Corporation.

Minneapolis, MN 55403

TM &©2017 Target Brands, Inc.

Tamper Evident Inner Unit

Do not use if sealed packet is Torn or Broken

DAYTIME SEVERE COLD AND COUGH AND NIGHTTIME SEVERE COLD AND COUGH 
acetaminophen, dextromethorphan hbr, diphenhydramine hcl, phenylephrine hcl kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11673-542
Packaging
#Item CodePackage Description
1NDC:11673-542-121 KIT in 1 CARTON
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 CARTON
Part 21 CARTON
Part 1 of 2
DAYTIME SEVERE COLD AND COUGH 
acetaminophen, dextromethorphan hbr, phenylephrine hcl powder, for solution
Product Information
Item Code (Source)NDC:11673-540
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN650 mg
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE20 mg
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE10 mg
Inactive Ingredients
Ingredient NameStrength
FD&C BLUE NO. 1 
ANHYDROUS CITRIC ACID 
MALTODEXTRIN 
POTASSIUM CHLORIDE 
FD&C RED NO. 40 
SILICON DIOXIDE 
SUCRALOSE 
SUCROSE 
Packaging
#Item CodePackage Description
1NDC:11673-540-066 POWDER, FOR SOLUTION in 1 CARTON
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34107/31/2017
Part 2 of 2
NIGHTTIME SEVERE COLD AND COUGH 
acetaminophen, diphenhydramine hcl, phenylephrine hcl powder, for solution
Product Information
Item Code (Source)NDC:11673-541
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN650 mg
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE10 mg
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID 
MALTODEXTRIN 
POTASSIUM CHLORIDE 
SILICON DIOXIDE 
SUCRALOSE 
SUCROSE 
FD&C YELLOW NO. 6 
Packaging
#Item CodePackage Description
1NDC:11673-541-066 POWDER, FOR SOLUTION in 1 CARTON
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34107/31/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34107/31/2017
Labeler - Target Corporation (006961700)

 
Target Corporation

Further information

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

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