MUCINEX CHILDRENS COUGH AND CONGESTION- dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride tablet, coated

Mucinex Childrens by

Drug Labeling and Warnings

Mucinex Childrens 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

Active ingredients (in each caplet)	Purposes
Dextromethorphan HBr 5 mg	Cough suppressant
Guaifenesin 100 mg	Expectorant
Phenylephrine HCl 2.5 mg	Nasal decongestant

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 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 your child get to sleep
  • nasal congestion due to a cold
  • stuffy nose

Warnings

Do not use in a child who is 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 child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.

Ask a doctor before use if the child has

• heart disease
• high blood pressure
• thyroid disease
• diabetes
• cough that occurs with too much phlegm (mucus)
• persistent or chronic cough that lasts such as occurs with asthma

When using this product do not use more than directed

Stop use and ask a doctor if

• nervousness, dizziness, or sleeplessness occur
• symptoms do not get better within 7 days or occurs with fever
• cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious condition.

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

Directions

• this product does not contain directions or complete warnings for adult use
• do not give more than directed (see Overdose warning)
• dose as follows or as directed by a doctor
• children 6 to under 12 years of age: give 2 caplets every 4 hours while symptoms last; do not give more than 6 doses in any 24-hour period
• children under 6 years of age: do not use

Other information

• store at 20-25°C (68-77°F)

Inactive ingredients

corn starch, FD&C blue no. 2 aluminum lake, FD&C red no. 40 aluminum lake, magnesium stearate, maltodextrin, mica, microcrystalline cellulose, polyethylene glycol, polysorbate 80, polyvinyl alcohol, povidone, silicon dioxide, sodium starch glycolate, stearic acid, talc, titanium dioxide

Questions?

1-866-MUCINEX (1-866-682-4639)

You may also report side effects to this phone number.

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 20 Caplet Blister Pack Carton

Pediatrician Recommended†
NDC: 63824-671-20
NEW

Mucinex®
Junior

COUGH & CONGESTION

Dextromethorphan HBr 5 mg – Cough Suppressant
Guaifenesin 100 mg – Expectorant
Phenylephrine HCl 2.5 mg – Nasal Decongestant

Ages
6+
yrs

✓ Relieves Chest Congestion

✓ Breaks up Mucus

✓ Relieves Stuffy Nose

✓ Controls Cough

Junior Caplet±
Actual Size

20 CAPLETS

DO NOT CHEW

INGREDIENTS AND APPEARANCE

MUCINEX CHILDRENS   COUGH AND CONGESTION
dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63824-671
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Dextromethorphan Hydrobromide (UNII: 9D2RTI9KYH) (Dextromethorphan - UNII:7355X3ROTS)	Dextromethorphan Hydrobromide	5 mg
Guaifenesin (UNII: 495W7451VQ) (Guaifenesin - UNII:495W7451VQ)	Guaifenesin	100 mg
Phenylephrine Hydrochloride (UNII: 04JA59TNSJ) (Phenylephrine - UNII:1WS297W6MV)	Phenylephrine Hydrochloride	2.5 mg

Inactive Ingredients
Ingredient Name	Strength
starch, corn (UNII: O8232NY3SJ)
FD&C blue no. 2 (UNII: L06K8R7DQK)
aluminum oxide (UNII: LMI26O6933)
FD&C red no. 40 (UNII: WZB9127XOA)
magnesium stearate (UNII: 70097M6I30)
maltodextrin (UNII: 7CVR7L4A2D)
mica (UNII: V8A1AW0880)
microcrystalline cellulose (UNII: OP1R32D61U)
polyethylene glycol, unspecified (UNII: 3WJQ0SDW1A)
polysorbate 80 (UNII: 6OZP39ZG8H)
polyvinyl alcohol, unspecified (UNII: 532B59J990)
povidone, unspecified (UNII: FZ989GH94E)
silicon dioxide (UNII: ETJ7Z6XBU4)
sodium starch glycolate type b potato (UNII: 27NA468985)
stearic acid (UNII: 4ELV7Z65AP)
talc (UNII: 7SEV7J4R1U)
titanium dioxide (UNII: 15FIX9V2JP)

Product Characteristics
Color	PURPLE	Score	no score
Shape	OVAL	Size	11mm
Flavor		Imprint Code	Mx;Jr
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63824-671-20	1 in 1 CARTON	04/01/2019
1		20 in 1 BLISTER PACK; 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	04/01/2019

Labeler - RB Health (US) LLC (081049410)