Mucinex Childrens Mighty Chews Night Time Cold and Flu

openFDA label record#

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Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

Brand name
Mucinex Childrens Mighty Chews Night Time Cold and Flu
Generic name
ACETAMINOPHEN, DEXTROMETHORPHAN HBR AND DOXYLAMINE SUCCINATE
Manufacturer
Reckitt Benckiser LLC
Product type
HUMAN OTC DRUG
SPL set ID
2ce31244-9c6c-b7dd-e063-6394a90a31a8
SPL ID
51bad8ca-7226-ecef-e063-6394a90a8fc3
Version
5
Effective date
2026-05-13
Source export date
2026-08-01
Source partition
11
Source file
https://download.open.fda.gov/drug/label/drug-label-0011-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-08-01/8ac060fefb6f4d67c41cc2c9e4330286ca93c48094c18386c11bf706a1d8bd34/drug-label-0011-of-0014.json.zip
Source manifest SHA-256
bdd1454d0606b622b70458a306b8a10d8a8787db06fd9f46e69c7f7a4524b630
Import run
20260801T225920Z
Imported at
2026-08-01 23:29:02
Harmonized routes table
Harmonized routes
ORAL

Warnings cross-check#

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Warnings sections page 1 of 1 · 1 matching rows.

warnings

Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if: ■ adult takes more than 6 doses (24 chewable tablets) in 24 hours, which is the maximum daily amount ■ child takes more than 5 doses (10 chewable tablets) in 24 hours, which is the maximum daily amount ■ taken with other drugs containing acetaminophen ■ adult has 3 or more alcoholic drinks every day while using this product Allergy alert: 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. 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 a doctor promptly. Do not use ■ to make a child sleepy ■ with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. ■ if the user is now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. Ask a doctor before use if you have ■ has liver disease ■ has a sodium-restricted diet ■ has glaucoma ■ has a breathing problem such as emphysema or chronic bronchitis ■ has difficulty in urination due to enlargement of the prostate gland ■ is a child with pain of arthritis Ask a doctor or pharmacist before use if you are ■ taking the blood thinning drug warfarin ■ taking sedatives or tranquilizers When using this product ■ do not use more than directed (see Overdose warning) ■ excitability may occur, especially in children ■ marked drowsiness may occur ■ alcohol, sedatives, and tranquilizers may increase the drowsiness effect ■ avoid alcoholic beverages ■ use caution when driving a motor vehicle or operating machinery Stop use and ask a doctor if ■ pain or cough gets worse or lasts more than 5 days (children) or 7 days (adults) ■ fever gets worse or lasts more than 3 days ■ redness or swelling is present ■ new symptoms occur ■ cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.