MUCINEX CHILDRENS COUGH MINI-MELTS ORANGE CREME- dextromethorphan hydrobromide and guaifenesin granule

United States - English - NLM (National Library of Medicine)

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Active ingredient:
Dextromethorphan Hydrobromide (UNII: 9D2RTI9KYH) (Dextromethorphan - UNII:7355X3ROTS), Guaifenesin (UNII: 495W7451VQ) (Guaifenesin - UNII:495W7451VQ)
Available from:
RB Health (US) LLC
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
- 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.
Authorization status:
OTC monograph final
Authorization number:
63824-942-02, 63824-942-18, 63824-942-31

MUCINEX CHILDRENS COUGH MINI-MELTS ORANGE CREME- dextromethorphan

hydrobromide and guaifenesin granule

RB Health (US) LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they

comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Mucinex Children's®

Cough Mini-Melts™ Orange Crème

Drug Facts

Active ingredients (in each

packet)

Purposes

Dextromethorphan HBr 5 mg

Cough suppressant

Guaifenesin 100 mg

Expectorant

Us es

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.

Warnings

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 such as occurs with smoking, asthma, chronic bronchitis, or emphysema

cough that occurs with too much phlegm (mucus)

When using this product do not use more than directed

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 condition.

If pregnant or breast-feeding, ask a healthcare 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

dose as follows or as directed by a doctor

Age

Dos e

adults and children 12 years of age and

over

2 to 4 packets every

4 hours

children 6 years to under 12 years of

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

Ques tions ?

1-866-682-4639

Dist. by: RB Health (US)

Parsippany, NJ 07054-0224

Made in Germany

PRINCIPAL DISPLAY PANEL - 12 Granule Packet Carton

Pediatrician Recommended*

NDC 63824-942-31

Mucinex®

Children's

COUGH

Dextromethorphan HBr 5 mg – Cough Suppressant

Guaifenesin 100 mg – Expectorant

Controls Cough

Relieves Chest Congestion

Breaks up Mucus

Ages

years

Orange Creme

Flavor

12 GRANULE PACKETS

MUCINEX CHILDRENS COUGH MINI-MELTS ORANGE CREME

dextromethorphan hydrobromide and guaifenesin granule

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 38 24-9 42

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

Dextro metho rpha n Hydro bro mide (UNII: 9 D2RTI9 KYH) (Dextro metho rphan -

UNII:7355X3ROTS)

De xtro me tho rpha n

Hydro bro mide

5 mg

Gua ifenesin (UNII: 49 5W7451VQ) (Guaifenesin - UNII:49 5W7451VQ)

Gua ife ne sin

10 0 mg

Inactive Ingredients

Ingredient Name

Stre ng th

ASPARTAME (UNII: Z0 H242BBR1)

CARBO MER HO MO PO LYMER TYPE A ( ALLYL PENTAERYTHRITO L CRO SSLINKED) (UNII: F6 8 VH75CJC)

CARBO XYMETHYLCELLULO SE SO DIUM, UNSPECIFIED FO RM (UNII: K6 79 OBS311)

MAGNESIUM STEARATE (UNII: 70 0 9 7M6 I30 )

MICRO CRYSTALLINE CELLULO SE (UNII: OP1R32D6 1U)

PO VIDO NE, UNSPECIFIED (UNII: FZ9 8 9 GH9 4E)

SO DIUM BICARBO NATE (UNII: 8 MDF5V39 QO)

SO RBITO L (UNII: 50 6 T6 0 A25R)

STEARIC ACID (UNII: 4ELV7Z6 5AP)

TALC (UNII: 7SEV7J4R1U)

RB Health (US) LLC

TRIETHYL CITRATE (UNII: 8 Z9 6 QXD6 UM)

Product Characteristics

Color

ORANGE

S core

S hap e

S iz e

Flavor

ORANGE

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 38 24-9 42-31

12 in 1 CARTON

0 3/31/20 19

1

1 in 1 PACKET; Type 0 : No t a Co mbinatio n Pro duct

2

NDC:6 38 24-9 42-18

18 in 1 CARTON

0 3/31/20 19

2

NDC:6 38 24-9 42-0 2

2 in 1 CARTON

2

1 in 1 PACKET; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC MONOGRAPH FINAL

pa rt341

0 3/31/20 19

Labeler -

RB Health (US) LLC (081049410)

Revised: 5/2019

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