Other
Drug Facts
Allergy warning: acetaminophen may cause severe skin reactions. Syhmptoms may include:
- Skin reddening
- Blisters
- Rash
If a skin reaction occurs, stop use and seek medical help right away.
The following Structured Product Label (SPL) was submitted to the FDA by Jhk Dba American Safety & First Aid for the product Maximum Strength Cold Tabs (NDC 73598-1342). 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, use, liver warning, sore throat warning, do not use, ask a doctor before use if you have, otc - ask doctor/pharmacist, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Drug Facts
Allergy warning: acetaminophen may cause severe skin reactions. Syhmptoms may include:
If a skin reaction occurs, stop use and seek medical help right away.
| Active ingredient (In Each Caplet) | Purpose |
|---|---|
| Acetaminophen 325 mg | pain reliever/fever reducer |
| Dextromethorphan HBr 10 mg | cough suppressant |
| Guaifenesin 100mg | expectorant |
| Phenylephrine HCl 5mg | nasal decongestant |
Temporarily relieves these symptoms due to the common cold:
This product contains acetaminophen. Severe liver damage may occur if you take:
If sore throat is severe, persists 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.
When using this product do not exceed recommended use.
Stop use and ask 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. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
corn starch, crospovidone, FD&C yellow # 6 aluminum lake, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, sodium starch glycolate, stearic acid,talc,titanium dioxide
1-866-651-3660 Monday-Friday 8am-5pm EST
This product is not manufactured or distributed by McNeil-PPC, Inc.
Owner of the registered trademark Tylenol®.
Product #1342
Maximum Strength
Cold Tabs
Pain Reliever/Fever Reducer
Decongestant/Expectorant
Cough Suppressant
Active ingredient:
Acetaminophen,
Dextromethorphan,
Guaifenesin, Phenylephrine
These quality comfort tablets are formulated and packaged for use in the
workplace and meet ANSI Z308.1-2021 standards. They are sealed in tamper-evi-
dent packets for safety and convenience.
80 Caplets • 2 Caplets Per Packet
* Please review the disclaimer below.