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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 Rb Health (us) Llc for the product Mucinex Fast-max Cold, Flu And Sore Throat (NDC 72854-162). 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, directions, otc - keep out of reach of children, warnings, other information, 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 caplet)
Acetaminophen 325 mg
Guaifenesin 200mg
Active ingredients Purposes
(in each caplet)
Acetaminophen 325 mg...Pain reliever/fever reducer
Guaifenesin 200mg..............................Expectorant
■ temporarily relieves these common cold and flu
symptoms:
■ minor aches and pains
■ headache
■ sore throat
■ helps loosen phlegm (mucus) and thin bronchial
secretions to rid the bronchial passageways of
bothersome mucus and make coughs more productive
■ temporarily reduces fever
If pregnant or breast-feeding, ask a health
professional before use.
Keep out of reach of children.
Overdose warning: 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.
Liver warning: This product contains acetaminophen.
Severe liver damage may occur if you take:
■ more than 12 caplets in 24 hours, which is the
maximum daily amount for this product
■ with other drugs containing acetaminophen
■ 3 or more alcoholic drinks daily 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
■ with any other drug containing acetaminophen
(prescription or nonprescription). If you are not
sure whether a drug contains acetaminophen,
ask a doctor or pharmacist.
Ask a doctor before use if you have
■ liver disease
■ persistent or chronic cough such as occurs with
smoking, asthma, chronic bronchitis, or emphysema
■ cough that occurs with too much phlegm (mucus)
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
Stop use and ask a doctor if
■ 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
croscarmellose sodium, FD&C red no. 40 aluminum
lake, FD&C yellow no. 6 aluminum lake, magnesium
stearate, microcrystalline cellulose, polyethylene
glycol, polyvinyl alcohol, povidone, talc, titanium
dioxide
1-866-MUCINEX (1-866-682-4639)
You may also report side effects to this phone number.
* Please review the disclaimer below.