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

AGRIFEN by

Drug Labeling and Warnings

AGRIFEN by is a Otc medication manufactured, distributed, or labeled by OPMX LLC, SOFTECH PHARMA PRIVATE LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

• Active ingredients (in each Softgel): Purposes
• Acetaminophen 325 mg: Pain reliever/Fever reducer
• Dextromethorphan HBr 10 mg: Cough suppressant
• Phenylephrine HCl 5mg: Nasal 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:

• More than 4 doses in 24 hrs, which is the maximum daily amount for this product.
• 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 reactions occurs, stop use and seek medical help right away

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

• Take only as directed.
• Do not exceed 4 doses per 24 hours.

• Adults & children 12 yrs & over: 2 softgels with water every 4 hrs
• Children 4 to under 12 yrs: Ask a doctor
• Children under 4 yrs: Do not use

Other information

• Store at room temperature.

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

PRINCIPAL DISPLAY PANEL

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

INGREDIENTS AND APPEARANCE

AGRIFEN 
acetaminophen, dextomethorphan hydrobromide, phenylephrine hydrochloride capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69729-802
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	10 mg

Inactive Ingredients
Ingredient Name	Strength
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
Color	red	Score	score with uneven pieces
Shape	OVAL (Oblong)	Size	20mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69729-802-10	1 in 1 CARTON	03/31/2025
1		10 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	03/31/2025

Labeler - OPMX LLC (029918743)

Establishment
Name	Address	ID/FEI	Business Operations
SOFTECH PHARMA PRIVATE LIMITED		677111277	manufacture(69729-802) , label(69729-802) , pack(69729-802)