CETAFEN COUGH AND COLD- cold medicine tablet 
HART Health

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.

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CETAFEN COUGH and COLD

Active Ingredients (in each tablet):

Acetaminophen 325 mg

Dextromethorphan HBr 15 mg

Guaifenesin 200 mg

Phenylephrine HCl 5 mg

Purpose:

Pain Reliever/Fever Reducer

Cough Suppressant

Expectorant

Nasal Decongestant

Uses:

Temporarily relieves these cold/flu symptoms

Temporarily reduces fever

Warnings:

Liver warning: This product contains acetaminophen.

Severe liver damage may occur if you take

Allergy alert: Acetaminophen may cause severe skin reactions.

Symptoms may include:

Sore throat warning:

If sore throat is severe, persists more than 2 days, is accompanied or followed by a fever, headache, rash, nausea or vomiting, consult a doctor right away.

Do not use

Ask a doctor or pharmacist before use if 

Ask a doctor before use if you have

Stop use and ask a doctor if

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.

Overdose wasrning:

Taking more than the recommended dose (overdose) may cause liver damage. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms. In case of overdose, get medical help or call a Poison Control Center right away. 1-800-222-1222

Directions:

Do not take more than directed.

Adults and children 12 years of age and over:

Children under 12 years of age: ask a doctor

Inactive Ingredients:

Maltodextrin, Microcrystalline Cellulose, Povidone, Sodium Starch Glycolate, Starch, Stearic Acid

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CETAFEN COUGH AND COLD 
cold medicine tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50332-0129
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE15 mg
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POVIDONE (UNII: FZ989GH94E)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
STARCH, CORN (UNII: O8232NY3SJ)  
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize12mm
FlavorImprint Code FR12
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50332-0129-450 in 1 BOX, UNIT-DOSE03/14/2007
12 in 1 PACKET; Type 0: Not a Combination Product
2NDC:50332-0129-7125 in 1 BOX, UNIT-DOSE03/14/2007
22 in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34303/14/2007
Labeler - HART Health (069560969)

Revised: 6/2020
Document Id: a79e9579-fa87-41ff-9b7b-c52dd5552252
Set id: 51346b5d-5928-4aca-982c-9bc994fda43b
Version: 2
Effective Time: 20200605
 
HART Health