FDA Label for Mucinex Fast-max Day Time Severe Congestion And Cough - Mucinex Fast-max Night Time Cold And Flu Maximum Strength

View Indications, Usage & Precautions

Mucinex Fast-max Day Time Severe Congestion And Cough - Mucinex Fast-max Night Time Cold And Flu Maximum Strength Product Label

The following document was submitted to the FDA by the labeler of this product Rb Health (us) Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Other

Drug Facts

Overdose warning (NIGHT TIME only)

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.

Dist. by: RB Health (US), Parsippany, NJ 07054-0224

Otc - Purpose

Active ingredients (in each caplet) Mucinex FAST-MAX DAY TIME SEVERE CONGESTION & COUGH	Purposes
Dextromethorphan HBr 10 mg	Cough suppressant
Guaifenesin 200 mg	Expectorant
Phenylephrine HCl 5 mg	Nasal decongestant

Active ingredients (in each caplet) Mucinex FAST-MAX NIGHT TIME COLD & FLU	Purposes
Acetaminophen 325 mg	Pain reliever/ fever reducer
Diphenhydramine HCl 12.5 mg	Antihistamine/cough suppressant
Phenylephrine HCl 5 mg	Nasal decongestant

Uses

temporarily relieves (DAY TIME only):
- cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
- the intensity of coughing
- nasal congestion due to a cold
- helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive (DAY TIME only)
- temporarily relieves these common cold and flu symptoms (NIGHT TIME only):
  - cough
  - minor aches and pains
  - headache
  - nasal congestion
  - sore throat
  - runny nose
  - sneezing
  - itching of the nose or throat
  - itchy, watery eyes due to hay fever
  - temporarily reduces fever (NIGHT TIME only)
  - controls cough to help you get to sleep

Liver Warning (Night Time Only)

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
with other drugs containing acetaminophen
3 or more alcoholic drinks daily while using this product

Allergy Alert (Night Time Only)

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 (Night Time Only)

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.

Otc - Do Not Use

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. (NIGHT TIME only)
with any other product containing diphenhydramine, even one used on the skin (NIGHT TIME only)
if you are 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.

Otc - Ask Doctor

Ask a doctor before use if you have

liver disease (NIGHT TIME only)
heart disease
diabetes
high blood pressure
thyroid disease
trouble urinating due to an enlarged prostate gland
glaucoma (NIGHT TIME only)
a breathing problem such as emphysema or chronic bronchitis (NIGHT TIME only)
persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
cough that occurs with too much phlegm (mucus)

Otc - Ask Doctor/Pharmacist

Ask a doctor or pharmacist before use if you are

taking the blood thinning drug warfarin (NIGHT TIME only)
taking sedatives or tranquilizers (NIGHT TIME only)

Otc - When Using

When using this product

do not use more than directed
excitability may occur, especially in children (NIGHT TIME only)
marked drowsiness may occur (NIGHT TIME only)
alcohol, sedatives, and tranquilizers may increase drowsiness (NIGHT TIME only)
avoid alcoholic drinks (NIGHT TIME only)
be careful when driving a motor vehicle or operating machinery (NIGHT TIME only)

Otc - Stop Use

Stop use and ask a doctor if

nervousness, dizziness, or sleeplessness occur
symptoms do not get better within 7 days or occur with fever (DAY TIME only)
pain, nasal congestion, or cough gets worse or lasts more than 7 days (NIGHT TIME only)
fever gets worse or lasts more than 3 days (NIGHT TIME only)
redness or swelling is present (NIGHT TIME only)
new symptoms occur (NIGHT TIME only)
cough lasts more than 7 days, comes back, or occurs with fever, rash, or headache that lasts. These could be signs of a serious condition.

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

do not take more than directed (see Overdose warning)
do not take more than 12 caplets in any 24-hour period
adults and children 12 years of age and over: take 2 caplets every 4 hours
children under 12 years of age: do not use

Other Information

store at 20-25°C (68-77°F)

Inactive Ingredients (Mucinex Fast-Max Day Time Severe Congestion & Cough)

croscarmellose sodium, FD&C blue no. 2 aluminum lake, FD&C red no. 40 aluminum lake, methacrylic acid-ethyl acrylate copolymer, mica, microcrystalline cellulose, polyethylene glycol 3350, polysorbate 80, polyvinyl alcohol, povidone K29/32, sodium bicarbonate, talc, titanium dioxide

Inactive Ingredients (Mucinex Fast-Max Night Time Cold & Flu)

croscarmellose sodium, crospovidone, FD&C blue no. 1 aluminum lake, FD&C blue no. 2 aluminum lake, ferric oxide yellow, methacrylic acid – ethyl acrylate copolymer (1:1) type A, mica, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, sodium bicarbonate, talc, titanium dioxide

Questions?

1-866-MUCINEX (1-866-682-4639) You may also report side effects to this phone number.

Principal Display Panel - Kit Carton

MAXIMUM STRENGTH
NDC 63824-558-40

Mucinex®
FAST-MAX^®

DAY
TIME
SEVERE CONGESTION
& COUGH

Dextromethorphan HBr – Cough Suppressant
Guaifenesin – Expectorant
Phenylephrine HCl – Nasal Decongestant

✓Controls Cough
✓Relieves Nasal & Chest
Congestion
✓Thins & Loosens Mucus

Actual Size

NIGHT
TIME
COLD & FLU

Acetaminophen – Pain Reliever/Fever Reducer
Diphenhydramine HCl – Antihistamine/
Cough Suppressant
Phenylephrine HCl – Nasal Decongestant

✓Relieves Aches & Sore Throat
✓Reduces Fever
✓Controls Cough
✓Relieves Nasal Congestion
✓Relieves Runny Nose
& Sneezing