Other
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 Nightshift (NDC 63824-503). 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, mucinex fast-max dm max, mucinex nightshift cold & flu, liver warning (nightshift cold & flu only), allergy alert (nightshift cold & flu only), 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 20 mL)
MUCINEX FAST-MAX DM MAX
Dextromethorphan HBr 20 mg Cough suppressant
Guaifenesin 400 mg Expectorant
Active ingredients (in each 20 mL)
MUCINEX NIGHTTIME COLD & FLU Purposes
Acetaminophen 650 mg Pain reliever/fever reducer
Dextromethorphan HBr 20 mg Cough suppressant
Triprolidine HCl 2.5 mg Antihistamine
| Active ingredients (in each 20 mL)
MUCINEX FAST-MAX DM MAX | Purposes |
|---|---|
| Dextromethorphan HBr 20 mg | Cough suppressant |
| Guaifenesin 400 mg | Expectorant |
| Active ingredients (in each 20 mL)
MUCINEX NIGHTTIME COLD & FLU | Purposes |
|---|---|
| Acetaminophen 650 mg | Pain reliever/fever reducer |
| Dextromethorphan HBr 20 mg | Cough suppressant |
| Triprolidine HCl 2.5 mg | Antihistamine |
helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
temporarily relieves:
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
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.
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Taking more than the recommended dose (overdose) may cause liver damage. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
ammonium glycyrrhizate, anhydrous citric acid, edetate disodium, FD&C red no. 40,
flavor, glycerin (soy), propyl gallate, propylene glycol, purified water, sodium benzoate,
sorbitol, sucralose, trisodium citrate dihydrate*, xanthan gum
*may contain this ingredient
ammonium glycyrrhizate, anhydrous citric acid, edetate
disodium, FD&C blue no. 1, FD&C red no.
40, flavor, glycerin (soy), propylene glycol,
purified water, sodium benzoate, sorbitol,
sucralose, xanthan gum
1-866-MUCINEX (1-866-682-4639) You may also report side effects to this phone number.
DAY & NIGHT
COUGH & COLD RELIEF
MAXIMUM STRENGTH
NDC 72854-165-26
Mucinex®
FAST-MAX
®
DM MAX
Dextromethorphan HBr – Cough Suppressant
Guaifenesin – Expectorant
Mucinex®
NIGHTTIME
COLD & FLU
Acetaminophen – Pain Reliever/Fever Reducer
Dextromethorphan HBr – Cough Suppressant
Triprolidine HCl – Antihistamine
NIGHTTIME
RELIEF FOR A BETTER
MORNING
✓COUGH ✓FEVER ✓SORE THROAT
✓RUNNY NOSE ✓SNEEZING
FOR
AGES 12+
TWO – 6 FL OZ (180 mL) bottles
TOTAL – 12 FL OZ (360 mL)
FOR
AGES 12+
* Please review the disclaimer below.