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Drug Facts
The following Structured Product Label (SPL) was submitted to the FDA by Opmx Llc for the product Rompe Tos X Children (NDC 69729-784). 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, 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 10 mL = 2 teaspoonful) | Purpose |
| Acetaminophen 250 mg | Pain reliever/fever reducer |
| Dextromethorphan HBr 13.33 mg | Cough suppressant |
| Guaifenesin 200 mg | Expectorant |
| Phenylephrine HCl 5 mg | Nasal descongestant |
temporarily relieves these common cold/flu symptoms:
This product contains acetaminophen. Severe liver damage may occur if you take:
• more than 6 doses in 24 hrs, which is the maximum daily amount for this product
• with other drugs containing acetaminophen
• 3 or more alcoholic drinks every day while using this product
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, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.
These could be signs of a serious condition.
ask a health professional before use.
Taking more than recommended dose (overdose) may cause liver damaage. 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.
| Age | Dose |
| Children 6 to under 12 years of age | 10 mL or 2 tsp provided every 4 hours |
| Children under 6 years of age | do not use |
Aloe vera, citric acid, disodium EDTA, FD&C red no. 40, hydroxyethyl cellulose, natural & artificial strawberry flavor, propylene glycol, purified water, sodium benzoate, sorbitol 70%, sucralose
Call 616-600-5632 MON to FRI, 9 a.m. to 6 p.m. PTZ
NDC 69729-784-06
Rompe Tos X
6 fl oz (177 mL)
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