CHILDRENS MUCUS RELIEF COUGH CHERRY- childrens mucinex cough liquid

Childrens Mucus Relief Cough Cherry by

Drug Labeling and Warnings

Childrens Mucus Relief Cough Cherry by is a Otc medication manufactured, distributed, or labeled by P & L Development, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Dextromethorphan HBr, USP 5 mg
Guaifenesin, USP 100 mg

SPL UNCLASSIFIED SECTION

Purposes

Dextromethorphan HBr, USP...............Cough suppressant
Guaifenesin, USP...................................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 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

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 the child has

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

Stop use and ask a doctor if

new symptoms occur
redness or swelling is present
fever gets worse or lasts more than 3 days
pain or cough gets worse or lasts more than
5 days (children)
cough comes back or occurs with fever, rash, or
headache that lasts. These could be signs
of a serious illness.

When using this product

do not use more than directed

Warnings

Keep this and all drugs out of the reach of children.

In case of accidental overdose, seek professional
assistance or contact a Poison Control Center
immediately.

Directions

do not exceed 6 doses in a 24-hour period

age                                                                dose
children 6 years to under 12 years           1-2 teaspoonfuls (tsps)every 4 hours
children 4 years to under 6 years             1/2-1 teaspoonful (tsp)every 4 hours
children under 4 years                               do not use

Other Information

each teaspoon contains: sodium 3 mg
store at controlled room temperature
dosage cup provided

Inactive Ingredients

citric acid anhydrous,
dextrose, flavors, glycerin, methyl paraben, potassium
sorbate, propylene glycol, propyl paraben,
purified water, red 33, red 40, saccharin sodium,
sodium hydroxide, sucralose, xanthan gum

Principal Display Panel

cherry children's mucus relief cough

dextromethorphan HBr

cough

guaifenesin

chest congestion and mucus

for ages 4 to 11

alcohol free

compare to the active ingredients

in children's mucinex cough

4 fl oz (118 mL)

INGREDIENTS AND APPEARANCE

CHILDRENS MUCUS RELIEF COUGH CHERRY 
childrens mucinex cough liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49580-0158
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  in 5 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	100 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
DEXTROSE (UNII: IY9XDZ35W2)
GLYCERIN (UNII: PDC6A3C0OX)
METHYLPARABEN (UNII: A2I8C7HI9T)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
FD&C RED NO. 40 (UNII: WZB9127XOA)
SACCHARIN SODIUM ANHYDROUS (UNII: I4807BK602)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SUCRALOSE (UNII: 96K6UQ3ZD4)
XANTHAN GUM (UNII: TTV12P4NEE)

Product Characteristics
Color		Score
Shape		Size
Flavor	CHERRY (Cherry Flavor)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49580-0158-4	118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/12/2013	12/30/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	12/12/2013	12/30/2021

Labeler - P & L Development, LLC (101896231)