CETAFEN COUGH AND COLD- acetaminophen, dextromethorphan hbr, phenylephrine hcl , guaifenesin, , tablet, film coated 
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 caplet)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Guaifenesin 100 mg

Phenylephrine HCl 5 mg

Purpose

Pain reliever/fever reducer

Cough suppressant

Expectorant

Nasal decongestant

Uses

Temporarily relieves these cold and 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 for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor right away.

Do not use

Ask a doctor before use if you have

Ask a doctor or pharmacist before use if

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 warning: 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 notice any signs or symptoms. In case of overdose, get medical help or contact 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

Other information:

Inactive ingredients corn starch, crospovidone, FD&C yellow # 6 aluminum lake, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone,silicon dioxide, sodium starch glycolate, stearic acid, talc, titanium dioxide

CetafenCough.jpg

CETAFEN COUGH AND COLD 
acetaminophen, dextromethorphan hbr, phenylephrine hcl , guaifenesin, , tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50332-0141
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN100 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg
Inactive Ingredients
Ingredient NameStrength
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
TALC (UNII: 7SEV7J4R1U)  
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
CROSPOVIDONE (UNII: 2S7830E561)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POVIDONE (UNII: FZ989GH94E)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
STARCH, CORN (UNII: O8232NY3SJ)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Product Characteristics
ColororangeScoreno score
ShapeCAPSULE (Caplet) Size17mm
FlavorImprint Code 44;546
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50332-0141-320 in 1 BAG01/09/2023
12 in 1 PACKET; Type 0: Not a Combination Product
2NDC:50332-0141-440 in 1 BOX01/09/2023
22 in 1 PACKET; Type 0: Not a Combination Product
3NDC:50332-0141-7100 in 1 BOX01/09/2023
32 in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34101/09/2023
Labeler - HART Health (069560969)

Revised: 8/2023
Document Id: 306e7e60-b982-4cac-9ce8-139debfc9b89
Set id: 44da0d8c-4a12-4122-99da-781e2809e1a8
Version: 2
Effective Time: 20230810
 
HART Health