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Drug Facts
Dist. by: RB Health (US), Parsippany, NJ 07054-0224
Made in England
The following Structured Product Label (SPL) was submitted to the FDA by Reckitt Benckiser Llc for the product Childrens Delsym (NDC 63824-212). 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, uses, liver warning, allergy alert, sore throat warning, do not use, ask a doctor before use if the child has, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Drug Facts
Dist. by: RB Health (US), Parsippany, NJ 07054-0224
Made in England
| Active ingredients (in each 10 mL) | Purposes |
|---|---|
| Acetaminophen 325 mg | Pain reliever/fever reducer |
| Diphenhydramine HCl 12.5 mg | Antihistamine/cough suppressant |
| Phenylephrine HCl 5 mg | Nasal decongestant |
This product contains acetaminophen. Severe liver damage may occur if your child takes:
Acetaminophen may cause severe skin reactions. Symptoms may include:
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.
Keep out of reach of children.
Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical even if you do not notice any signs or symptoms.
anhydrous citric acid, edetate disodium, FD&C blue no. 1, FD&C red no. 40, flavors, glycerin, propyl gallate, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, trisodium citrate dihydrate
may contain this ingredient
, xanthan gum1-866-682-4639
You may also report side effects to this phone number.
NDC 63824-212-64
Ages 6 Years+
Children's
Delsym®
COUGH + Cold
Night Time
Acetaminophen (Pain Reliever/Fever Reducer)
Diphenhydramine HCl (Antihistamine/Cough Suppressant)
Phenylephrine HCl (Nasal Decongestant)
Berry Flavor
4 fl oz (118 mL)
* Please review the disclaimer below.