Otc - Active Ingredient
ACTIVE INGREDIENTS (in each tablet)
Acetaminophen 500 mg
Chlorpheniramine Maleate 4 mg
Phenylephrine HCl 10 mg
The following Structured Product Label (SPL) was submitted to the FDA by Opmx Llc for the product Coldtac Ultra (NDC 69729-133). 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, indications & usage, warnings, otc - do not use, otc - ask doctor, otc - ask doctor/pharmacist, otc - when using, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
ACTIVE INGREDIENTS (in each tablet)
Acetaminophen 500 mg
Chlorpheniramine Maleate 4 mg
Phenylephrine HCl 10 mg
PURPOSE
Pain Reliever/Fever Reducer
Antihistamine
Nasal decongestant
Uses:
Warnings
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:
If a skin reaction occurs, stop use and seek medical help right away.
Sore throat warning:if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult doctor promptly
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:
Stop use and ask a doctor if:
These could be signs of a serious condition.
If pregnant or breast-feeding:ask a health professional before use.
Keep out of reach of children.
Overdose warning:Taking more tahn directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Directions:
| Adults and children 12 years of age & over | 1 tablet with water every 4-6 hours as needed |
| Children 4 to 12 years of age | Ask a doctor |
| Children under 4 years of age | Do not use |
Other information:
Inactive ingredients:magnesium stearate, povidone, silicon dioxide, sodium benzoate, sodium starch glycolate, starch, talc
Questions or comments?
Call: (619) 600-5632 (Mon-Fri 9am-5pm EST) or https://www.opmx.us
TAMPER EVIDENT: DO NOT USE IF POUCH IS TORN, BROKEN OR SHOWS ANY SIGN OF TAMPERING
Exclusively distributed by:
OPMX
San Diego, CA 92154
Phone: 619-600-5632
NDC 69729-133-38
COLDTAC ULTRA
Actaminophen 500 mg, Chlorpheniramine Maleate 4 mg, Phenylephrine HCl 10 mg
Effective and Quick Relief from Cold & Flu Symptoms
Headache
Fever
Body Aches
Sneezing
Runny Nose
Watery Eye
Nasal Congestion
Sore Throat
144 Tablets (72 Packs of 2 tablets)
NDC 69729-133-38
COLDTAC ULTRA
Actaminophen 500 mg, Chlorpheniramine Maleate 4 mg, Phenylephrine HCl 10 mg
Effective and Quick Relief from Cold & Flu Symptoms
Headache
Fever
Body Aches
Sneezing
Runny Nose
Watery Eye
Nasal Congestion
Sore Throat
12 Tablets (6 Packs of 2 tablets)
NDC 69729-133-06
COLDTAC ULTRA
Actaminophen 500 mg, Chlorpheniramine Maleate 4 mg, Phenylephrine HCl 10 mg
Effective and Quick Relief from Cold & Flu Symptoms
Headache
Fever
Body Aches
Sneezing
Runny Nose
Watery Eye
Nasal Congestion
Sore Throat
6 Tablets (3 Packs of 2 tablets)
NDC 69729-133-27
COLDTAC ULTRA
Actaminophen 500 mg, Chlorpheniramine Maleate 4 mg, Phenylephrine HCl 10 mg
Effective and Quick Relief from Cold & Flu Symptoms
Headache
Fever
Body Aches
Sneezing
Runny Nose
Watery Eye
Nasal Congestion
Sore Throat
2 Tablets
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