CHILDRENS MUCINEX MINI-MELTS CHEST CONGESTION- guaifenesin granule

Childrens Mucinex by

Drug Labeling and Warnings

Childrens Mucinex by is a Otc medication manufactured, distributed, or labeled by RB Health (US) LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each packet)

Guaifenesin 100 mg

Purpose

Expectorant

Uses

helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

Warnings

Ask a doctor before use if you have

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

Stop use and ask a doctor if cough lasts more than 7 days, comes back, or occurs with fever, rash, or headache that lasts. These could be signs of a serious illness.

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.

Directions

• empty entire contents of packet onto tongue and swallow
• for best taste, do not chew granules
• do not take more than 6 doses in any 24-hour period

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

Other information

• each packet contains: magnesium 6 mg and sodium 3 mg
• phenylketonurics: contains phenylalanine 1 mg per packet
• store between 20-25°C (68-77°F)
• tamper evident: do not use if carton is open or if packets are torn or open

Inactive ingredients

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

Questions?

1-866-682-4639

You may also report side effects to this phone number.

SPL UNCLASSIFIED SECTION

Dist. by: Reckitt Benckiser
Parsippany, NJ 07054-0224

PRINCIPAL DISPLAY PANEL - 12 Packet Carton

NDC: 63824-254-12

Children's
Mucinex®

Chest Congestion
Guaifenesin 100 mg
Expectorant

minimelts™

Age 4+

• ✔ Chest Congestion
• ✔ Breaks up Mucus

Bubble Gum
Flavor

12 GRANULE PACKETS

INGREDIENTS AND APPEARANCE

CHILDRENS MUCINEX   MINI-MELTS CHEST CONGESTION
guaifenesin granule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63824-254
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Guaifenesin (UNII: 495W7451VQ) (Guaifenesin - UNII:495W7451VQ)	Guaifenesin	100 mg

Inactive Ingredients
Ingredient Name	Strength
aspartame (UNII: Z0H242BBR1)
carbomer homopolymer type A (allyl pentaerythritol crosslinked) (UNII: F68VH75CJC)
carboxymethylcellulose sodium, unspecified form (UNII: K679OBS311)
magnesium stearate (UNII: 70097M6I30)
cellulose, microcrystalline (UNII: OP1R32D61U)
povidones (UNII: FZ989GH94E)
sodium bicarbonate (UNII: 8MDF5V39QO)
sorbitol (UNII: 506T60A25R)
stearic acid (UNII: 4ELV7Z65AP)
talc (UNII: 7SEV7J4R1U)
triethyl citrate (UNII: 8Z96QXD6UM)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor	BUBBLE GUM	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63824-254-12	12 in 1 CARTON	06/11/2012
1		1 in 1 PACKET; Type 0: Not a Combination Product
2	NDC: 63824-254-18	18 in 1 CARTON	08/01/2016
2	NDC: 63824-254-02	2 in 1 CARTON
2		1 in 1 PACKET; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	03/24/2009

Labeler - Reckitt Benckiser (094405024)