AGRIFEN- acetaminophen, dextomethorphan hydrobromide, phenylephrine hydrochloride capsule, liquid filled 
OPMX LLC

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AGRIFEN

Active ingredient

Active ingredients (in each Softgel)Purposes
Acetaminophen 325 mgPain reliever/Fever reducer
Dextromethorphan HBr 10 mgCough suppressant
Phenylephrine HCl 5mgNasal descongestant

Uses

Temporarily relieves common cold/flu symptoms:

  • Nasal congestion
  • Cough due to minor throat & bronchial irritation
  • Sore throat
  • Headache
  • Minor aches and pains
  • Fever

Uses

  • Pain reliever/Fever reducer
  • Cough suppressant
  • Nasal descongestant

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, lasts for more than 2 days, is accompained or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly

Do not use

  • 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
  • Hear disease
  • Diabetes
  • High blood pressure
  • Trouble urinating due to enlarged prostate gland
  • Cough that occurs with too mcuh plegm (mucus)
  • Persistent or chronic cough occurs with smoking, asthma, chronic bronchitis or emphysema

Ask a doctor or pharmacist before use if you are:

Taking the blood thinning drug warfarin.

When using this product,

do not use more than directed.

Stop use and ask a doctor if

  • You get nervous, dizzy or sleepless
  • Symptoms get worse or last more than 5 days (children) or 7 days (adults)
  • Fever gets worse or lasts more than 3 days
  • Redness or swelling is present
  • New symptoms occur
  • Cough comes back, or occurs with rash or headache that lasts. These could be signs of a serious condition

Keep out of reach of children

If pregnant or breast-feeding

ask a health professional before use.

Overdose warning:

Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away.

Quick medical attention is critical for adults as well as for children even if you dot notice any signs or symptoms.

Directions

Adults & children 12 yrs & over2 softgels with water every 4 hrs
Children 4 to under 12 yrsAsk a doctor
Children under 4 yrsDo not use

Other information

Inactive ingredients

FD&C Red No.40, FD&C Yellow No. 6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol, titanium dioxide.

Questions?

Call toll free 619-600-5632

Monday through Friday 9AM - 5PM EST

NDC 69729-802-10

AGRIFEN

Acetaminophen 325 mg

Dextomethorphan HBr 10 mg

Phenylephrine HCl 5 mg

Dolor de Cabeza

Headache

Congestión Nasal

Nassal Congestion

Ojos llorosos

Itchi, Watery eyes

Escurrimiento Nasal y Estornudos

Runny Nose & Sneezing

10 Soft Gels

Exclusively distributes by:

OPMX

Chula Vista, CA 91910

Phine: 619-600-5632

TAMPER EVIDENT:

Do not use if package is opened or if blister unit is torn, broken or shows any sign of tampering

agrifen

2

AGRIFEN 
acetaminophen, dextomethorphan hydrobromide, phenylephrine hydrochloride capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69729-802
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg
Inactive Ingredients
Ingredient NameStrength
FD&C RED NO. 40 (UNII: WZB9127XOA)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
POVIDONE (UNII: FZ989GH94E)  
SORBITOL (UNII: 506T60A25R)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
GELATIN (UNII: 2G86QN327L)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorredScorescore with uneven pieces
ShapeOVAL (Oblong) Size20mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69729-802-101 in 1 CARTON03/31/2025
110 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01203/31/2025
Labeler - OPMX LLC (029918743)
Establishment
NameAddressID/FEIBusiness Operations
SOFTECH PHARMA PRIVATE LIMITED677111277manufacture(69729-802) , label(69729-802) , pack(69729-802)

Revised: 3/2025
Document Id: 31aaa8e7-7981-1e00-e063-6294a90a18d0
Set id: 31aaa8e7-7980-1e00-e063-6294a90a18d0
Version: 1
Effective Time: 20250331
 
OPMX LLC