CHILDRENS MUCUS RELIEF COUGH - CHERRY FLAVOR- dextromethorphan hydrobromide, guaifenesin liquid

CHILDRENS MUCUS RELIEF COUGH - CHERRY FLAVOR by

Drug Labeling and Warnings

CHILDRENS MUCUS RELIEF COUGH - CHERRY FLAVOR by is a Otc medication manufactured, distributed, or labeled by AptaPharma Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

DRUG FACTS

Active ingredients
(in each 5 mL teaspoonful)
Dextromethorphan HBr, USP 5 mg
Guaifenesin, USP 100 mg

PURPOSE

Purpose
Dextromelhorphan HBr, USP ....... Cough Suppressant
Guaifenestn,USP ........................Expectorant

INDICATIONS & USAGE

Uses

temporarily relieves:cough due to minor throat and bronchial irritation as may occur with a cold 

helps loosen phlegm (mucus) and thin bronchial secretions to drain the bronchial tube

WARNINGS

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

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 persistent headache.
These could be signs of a serious condition.

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.

DOSAGE & ADMINISTRATION

Directions
do not take more than 6 doses in any 24-hour period

                                  Age                                                                                            Dose

• Children 6 years toUnder 12 years: 1 to 2 teaspoonfuls (tsps); every 4 hours
• Children 4 years toUnder 6 years: 1/2 to 1 teaspoonful (tsp); every 4 hours
• Children under 4 years: do not use

OTHER SAFETY INFORMATION

Other information each teaspoon contains: sodium 3 mg

store between 20-25°C (68-77°F) do not refrigerate

dosing cup provided Keep carton for full direction for use

INACTIVE INGREDIENT

Inactive ingredients:anhydrous citric acid, dextrose, D&C red
#33, FD&C red #40, flavors, glycerin, maltitol, propylene glycol,
purified water, saccharin sodium, sodium benzoate, sucralose,
xanthan gum

QUESTIONS

Questions? Call weekdays from 9:30AM to 4:30 PM EST 1-877-798-5944

CHILDREN'S MUCUS RELIEF COUGH CHERRY

AP SAFE                        NDC: 76281-512-24

Children's                                        
Cough
Mucus Relief

Cough Suppressant
Expectorant

Cherry Flavor
4 FL OZ (118 mL)

DO NOT USE IF PRINTED SEAL UNDER CAP IS TORN OR MISSING

*This product is not manufactured or distributed by
Reckitt Benckiser Inc., distributor of Children's
Mucinex®Cough.

Manufactured by:
AptaPharma Inc.,
1533 Union Ave.
Pennsauken, NJ 08110

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INGREDIENTS AND APPEARANCE

CHILDRENS MUCUS RELIEF COUGH - CHERRY FLAVOR 
dextromethorphan hydrobromide, guaifenesin liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76281-512
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)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)
MALTITOL (UNII: D65DG142WK)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SUCRALOSE (UNII: 96K6UQ3ZD4)
XANTHAN GUM (UNII: TTV12P4NEE)

Product Characteristics
Color	red	Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76281-512-24	1 in 1 CARTON	01/30/2024
1		118 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	01/30/2024

Labeler - AptaPharma Inc. (790523323)

Registrant - AptaPharma Inc. (790523323)

Establishment
Name	Address	ID/FEI	Business Operations
AptaPharma Inc.		790523323	manufacture(76281-512)