Otc - Active Ingredient
Drug Facts
The following Structured Product Label (SPL) was submitted to the FDA by Opmx Llc. for the product Coldtac Plus Softgels (NDC 69729-120). 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 otc - active ingredient, 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
| Active ingredients (in each Softgel) | Purpose |
|---|---|
| Acetaminophen 325 mg | Pain reliever/fever reducer |
| Dextromethorphan HBr 10 mg | Cough suppressant |
| Phenylephrine HCl 5 mg | Nasal decongestant |
Temporarily relieves common cold/flu symptoms:
This product contains acetaminophen. Severe liver damage may occur if you take:
Acetaminophen may cause severe skin reactions. Symtoms may include.
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.
Ask a doctor or pharmacist before use if you are: Taking the blood thinning drug warfarin.
do not use more than directed.
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 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 special, titanium dioxide.
Call to free 619-600-5632 Monday throughFriday 9AM - 5PM EST
Made for:
RRX
Exclusively distributed by:
OPMX
Chula Vista, CA 91910
Phone: 619-600-5632
NDC 69729-120-10
Coldtac Plus
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Phenylephrine HCl 5mg
Pain reliever, fever reducer/ Fiebre y cuerpo cortado
Nasal Descongestant/ Descongestivo nasal
Cough Suppressant/ Supresor de la tos
Contents/Content
10 Softgels/ Capsulas de Gel
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