Drug Facts
Active ingredients (in each Softgel)
Acetaminophen 325mg
Dextromethorphan HBr 10mg
The following Structured Product Label (SPL) was submitted to the FDA by Opmx Llc for the product Coldtac Severe Cold (NDC 69729-808). 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 drug facts, purpose, uses, warnings, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are:, when using this product,, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Active ingredients (in each Softgel)
Acetaminophen 325mg
Dextromethorphan HBr 10mg
Temporarily relieves common cold/flu symptoms:
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 accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.
Taking the blood thinning drug warfarin.
do not use more than directed.
These could be signs of a serious condition.
Keep out of reach of children.
ask a health professional before use.
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 do not notice any signs or symptoms.
| 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 |
FD&C Red No. 40, FD&C Yellow No. 6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol, titanium dioxide.
Call toll free 619-600-5632
Monday through Friday 9AM - 5PM EST
Made for:
RRX
San Diego, CA 92154
Exlusivley distributeed by:
OPMX
Chula Vista, CA 91910
Phone: 619-600-5632
NDC 69729-808-10
COLDTAC
SEVERE COLD
Acetaminophen 325mg / Dextromethorphan HBr 10mg
MAX RELIEF
Cold and Flu Relief:
Para el alivio de las molestias de la Gripe:
Headache & Sore Throat
Dolor de Cabeza y Garganta
Fever Reducer
Reduce la Fiebre
Cough Suppressant
Supresor de la Tos
10 Soft Gels
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