Label: AGRIFEN- acetaminophen, dextomethorphan hydrobromide, phenylephrine hydrochloride capsule, liquid filled
- NDC Code(s): 69729-802-10
- Packager: OPMX LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated March 31, 2025
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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 -
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
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
- Directions
- Other information
- Inactive ingredients
- Questions?
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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
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INGREDIENTS AND APPEARANCE
AGRIFEN
acetaminophen, dextomethorphan hydrobromide, phenylephrine hydrochloride capsule, liquid filledProduct 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)