Other
Drug Facts
Made for:
RRX
Exclusively distributed by:
OPMX
Chula Vista, CA 91910
The following Structured Product Label (SPL) was submitted to the FDA by Opmx Llc for the product Ampigrin Ultra Forte Night (NDC 69729-003). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, otc - purpose, uses, liver warning, allergy alert, sore throat warning, do not use, ask a doctor before use if you have, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Drug Facts
Made for:
RRX
Exclusively distributed by:
OPMX
Chula Vista, CA 91910
| Active ingredients (in each Softgels) | Purpose |
|---|---|
| Acetaminophen 325 mg | Pain reliever/fever reducer |
| Dextromethorphan HBr 15 mg | Cough suppressant |
| Doxylamine succinate 6.25 mg | Antihistamine |
Temporarily relieves common cold/flu symptoms:
This product contains acetaminophen. Severe liver damage may occur if you take
Acetaminophen may cause severe skin reactions. Symptoms may include:
• skin reddening • blisters • rash • If a skin reaction occurs, stop use and seek medical help right away
If sore throat is severe, lasts for more than 2 days, occurs with or is followed by fever, headache, rash, nausea, or vomiting, see a doctor promptly.
ask a health professional before use.
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults & for children even if you do not notice any signs or symptoms.
| Adults & children 12 yrs & over | 2 softgels with water every 6 hrs |
| Children 4 to under 12 yrs | Ask a doctor |
| Children under 4 yrs | Do not use |
D&C Yellow No. 10, FD&C Blue No. 1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol special, titanium dioxide
Call toll free 619-600-5632 Monday through Friday 9AM - 5PM EST
NDC 69729-003-10
Ampigrin Ultra Forte
Acetaminophen 325 mg Pain Reliever/Fever Reducer
Dextromethorphan HBr 15 mg, Cough suppressant
Doxylamine Succinate 6.25 mg Antihistamine
COLD & COUGH
10 Softgels
* Please review the disclaimer below.