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

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CHILDREN'S MUCUS RELIEF COUGH - CHERRY FLAVOR

DRUG FACTS

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

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

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

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

                                  Age                                                                                            Dose

Children 6 years to
Under 12 years
1 to 2 teaspoonfuls (tsps)
every 4 hours
Children 4 years to
Under 6 years
1/2 to 1 teaspoonful (tsp)
every 4 hours
Children under 4 yearsdo not use

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 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? 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

512 Cartn

512 Botl

res

CHILDRENS MUCUS RELIEF COUGH - CHERRY FLAVOR 
dextromethorphan hydrobromide, guaifenesin liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76281-512
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE5 mg  in 5 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN100 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
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
ColorredScore    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76281-512-241 in 1 CARTON01/30/2024
1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01201/30/2024
Labeler - AptaPharma Inc. (790523323)
Registrant - AptaPharma Inc. (790523323)
Establishment
NameAddressID/FEIBusiness Operations
AptaPharma Inc.790523323manufacture(76281-512)

Revised: 1/2024
Document Id: 8fbbce0a-1d4c-4afb-8869-a55b94276835
Set id: 9ae6fe74-80cd-482a-b3b9-3acafd6708ec
Version: 3
Effective Time: 20240131
 
AptaPharma Inc.