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Drug Facts
Dist. by: RB Health (US)
Parsippany, NJ 07054-0224
The following Structured Product Label (SPL) was submitted to the FDA by Reckitt Benckiser Llc for the product Mucinex Rapid Clear Daytime Pain, Headache, And Cough (NDC 72854-214). 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 - active ingredient, otc - purpose, uses, warnings, liver warning, allergy alert, sore throat warning, 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
Active ingredients (in each liquid gel) Purposes
Acetaminophen 325 mg Pain reliever/fever reducer
Dextromethorphan HBr 10 mg Cough suppressant
| Active ingredients (in each liquid gel) | Purposes |
|---|---|
| Acetaminophen 325 mg | Pain reliever/fever reducer |
| Dextromethorphan HBr 10 mg | Cough suppressant |
temporarily relieves these common cold and flu symptoms:
■ cough due to minor throat and bronchial irritation as
may occur with the common cold or inhaled irritants
■ the intensity of coughing
■ the impulse to cough to help you get to sleep
■ minor aches and pains
■ sore throat
■ headache
■ temporarily reduces fever
This product contains acetaminophen. Severe liver damage may occur if you take:
more than 12 liquid gels in 24 hours, which is the maximum daily amount
with other drugs containing acetaminophen
3 or more alcoholic drinks daily while using this product
This product contains acetaminophen. Severe liver damage may occur if you take:
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.
Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin
When using this product do not use more than directed
■ pain or cough gets worse or lasts more than 7 days
■ 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.
If pregnant or breast-feeding, ask a health professional before use.
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 for adults as well as for children even if you do not notice any signs or symptoms.
FD&C red no. 40, FD&C yellow
no. 6, gelatin, glycerin, hypromellose, isopropyl alcohol,
lecithin (sunflower), light mineral oil, mannitol, polyethylene
glycol 400, povidone, propylene glycol, purified water,
1,4-sorbitan, sorbitol, titanium dioxide
1-866-MUCINEX (1-866-682-4639)
You may also report side effects to this phone number.
Fast Dissolving Liquid Gels!
NDC 72854-214
MAXIMUM STRENGTH
MUCINEX®
Acetaminophen – Pain Reliever/Fever Reducer
Dextromethorphan HBr – Cough Suppressant
LIQUID GELS
(Liquid Filled Capsules)
Actual Size
FOR AGES 12 +
* Please review the disclaimer below.