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Night Time Severe Cold and Cough

Medically reviewed on Feb 14, 2017

Dosage form: syrup
Ingredients: ACETAMINOPHEN 650mg in 30mL, DIPHENHYDRAMINE HYDROCHLORIDE 25mg in 30mL, PHENYLEPHRINE HYDROCHLORIDE 10mg in 30mL
Labeler: Fred's, Inc.
NDC Code: 55315-004

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

Active ingredients

(in each 30 mL (2 TBSP))

Acetaminophen, USP 650 mg
Diphenhydramine HCl, USP 25 mg
Phenylephrine HCl, USP 10 mg

Purposes

Pain Reliever/Fever Reducer
Antihistamine/Cough suppressant
Nasal decongestant

Uses
  • 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

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 daily 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 other 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 operating 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 this and all drugs out of the reach of children.

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) immediately. Quick 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
  • measure the dose correctly using the enclosed dosing cup
  • take every 4 hours in dosing cup provided, while symptoms persist
  • do not take more than 5 doses (150 mL) (10 TBSP) in 24 hours unless directed by a doctor
  • TBSP = Tablespoon, mL = milliliter

Age
Dose
adults and children 12 years of age and over
30 mL (2 TBSP)
children under 12 years of age
do not use

Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.

Other information
  • each 30 mL contains: potassium 9 mg, sodium 15 mg
  • Store at 20-25oC (68-77oF)
  • TAMPER EVIDENT: Do not use if printed seal over cap is broken or missing

Inactive ingredients

acesulfame potassium, alcohol, anhydrous citric acid, edetate disodium, FD&C Blue no.1, FD&C Red #40, flavors, glycerin, maltitol solution, propylene glycol, purified water, sodium benzoate, sodium citrate

Questions or comments?

1-855-274-4122

*This product is not manufactured or distributed by Novartis Consumer Health, Inc., owner of the registered trademark Theraflu® ExpressMax™ Nighttime Severe Cold & Cough.

TAMPER EVIDENT: DO NOT USE IF PRINTED SEAL OVER CAP IS BROKEN OR MISSING.

DISTRIBUTED BY:
Fred's, Inc.
4300 NEW GETWELL RD
MEMPHIS, TN38118
www.fredsinc.com

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 8.3 FL OZ (245.5 mL Bottle)

freds
Pharmacy


NDC 55315-004-33

Nighttime
SEVERE COLD
& COUGH
Maximum Strength Per 4 Hour Dose

Each dose (per 30 mL) of Syrup contains:
650 mg - ACETAMINOPHEN, USP
(Pain Reliever/Fever Reducer)
25 mg - DIPHENHYDRAMINE HCl, USP
(Cough Suppressant/Antihistamine)
10 mg - PHENYLEPHRINE HCl, USP
(Nasal Decongestant)


  • Nasal Congestion
  • Headache
  • Sore Throat Pain
  • Runny Nose
  • Body Ache
  • Cough
  • Fever

8.3 FL OZ (245.5 mL)

Berry Flavor
Alcohol Content: 10%

Compare to the Active Ingredients In
Theraflu® ExpressMaxTM
Nighttime Severe Cold&Cough*



NIGHT TIME SEVERE COLD AND COUGH 
acetaminophen, diphenhydramine hcl and phenylephrine hcl syrup
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55315-004
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN650 mg  in 30 mL
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE25 mg  in 30 mL
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE10 mg  in 30 mL
Inactive Ingredients
Ingredient NameStrength
ACESULFAME POTASSIUM 
ALCOHOL 
ANHYDROUS CITRIC ACID 
EDETATE DISODIUM 
FD&C BLUE NO. 1 
FD&C RED NO. 40 
BERRY 
PINEAPPLE 
GLYCERIN 
MALTITOL 
PROPYLENE GLYCOL 
WATER 
SODIUM BENZOATE 
SODIUM CITRATE 
Product Characteristics
ColorRED (Red Colored Liquid) Score    
ShapeSize
FlavorBERRY, PINEAPPLEImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:55315-004-33245.5 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34106/09/2016
Labeler - Fred's, Inc. (005866116)
Registrant - Aurohealth LLC (078728447)
Establishment
NameAddressID/FEIOperations
Aurohealth LLC078728447MANUFACTURE(55315-004)

 
Fred's, Inc.

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Further information

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

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