Mucinex Childrens Granule
FDA Label NDC 63824-943

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Reckitt Benckiser Llc for the product Mucinex Childrens (NDC 63824-943). 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 - purpose, uses, otc - do not use, ask a doctor before use if you have, otc - when using, otc - stop use, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Other

→ Otc - Purpose

→ Uses

→ Otc - Do Not Use

→ Ask A Doctor Before Use If You Have

→ Otc - When Using

→ Otc - Stop Use

→ Otc - Pregnancy Or Breast Feeding

→ Otc - Keep Out Of Reach Of Children

→ Directions

→ Other Information

→ Inactive Ingredients

→ Questions?

→ Principal Display Panel - 12 Packet Carton

Other

Drug Facts

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

Made in Germany

Otc - Purpose

Active ingredients (in each packet)	Purposes
Dextromethorphan HBr 5 mg	Cough suppressant
Guaifenesin 100 mg	Expectorant

Uses

helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
temporarily relieves cough as may occur with a cold.

Otc - Do Not Use

Do not use 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.

Ask A Doctor Before Use If You Have

persistent or chronic cough that lasts such as occurs with smoking, asthma, chronic bronchitis, or emphysema
cough accompanied by too much phlegm (mucus)

Otc - When Using

When using this product do not use more than directed

Otc - Stop Use

Stop use and ask a doctor if cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. 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

empty entire contents of packet onto tongue and swallow
for best taste, do not chew granules
do not give more than 6 doses in any 24-hour period
dose as follows or as directed by a doctor

Age	Dose
adults and Children 12 years of age and over	2 to 4 packets every 4 hours
children 6 years to under 12 years of age	1 to 2 packets every 4 hours
children 4 years to under 6 years of age	1 packet every 4 hours
children under 4 years of age	do not use

Other Information

each packet contains: magnesium 6 mg and sodium 3 mg
phenylketonurics: contains phenylalanine 2 mg per packet
store at 20-25°C (68-77°F)

Inactive Ingredients

aspartame, butylated methacrylate copolymer, carbomer homopolymer type A, carboxymethylcellulose sodium, creme flavor, magnesium stearate, microcrystalline cellulose, orange flavor, povidone, sodium bicarbonate, sorbitol, stearic acid, talc, triethyl citrate