TUSSIN COUGH EXPECTORANT COUGH SUPRESSANT DM- dextromethorphan hydrobromide liquid 
AptaPharma Inc.

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Drug Facts

Active ingredients (in each 5mL tsp)
Dextromethorphan HBr, USP 10mg 
Guaifenesin, USP 100mg

Purpose
Dextromethorphan HBr, USP .... Cough Suppressant
Guaifenesin, USP .............................. Expectorant

Uses
■ temporarily relieves cough due to minor throat and
   bronchial irritation as may occur with acold
■ helps loosen phlegm (mucus) and thin bronchial
   secretions to drain bronchial tubes

Warnings
Do not use ■ in a child under 12 years of age
■ if you are now taking aprescription monoamine
oxidase inhibitor (MAOI) (certain drugs for
depression, psychiatric or emotional conditions, or
Parkinson's disease) or for 2 weeks atter stopping
the MAOI drug. If you do not know if your
prescription drug contains a MAOI, ask adoctor or
pharmacist before using this product.

Ask a doctor before use if you have
■ cough that occurs with too much phlegm (mucus)
■ cough that lasts or chronic, such as occurs with
smoking, asthma, chronic bronchitis or emphysema

Stop use and ask a doctor if cough lasts more than 7
days, comes back or is accompanied by fever. rash or
persistent headache. These could be signs of a
serious condition.

If pregnant or breast-feeding, ask ahealth
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

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

------------------------------------------------------------------------

 Age                                       Dose
------------------------------------------------------------------------
Adults and children                 2 teaspoonfuls
12 years and over                    every 4 hours
------------------------------------------------------------------------
children under 12 years          do not use
_________________________________________

Other information

■ store at 20-25°C (68-77°F) ■ do not refrigerate
■ dosage cup provided ■ sodium 3 mg per
   teaspoonful
 Keep carton for full directions for use.

Inactive ingredientsAnhydrous citric acid,
dextrose, FD&C red #40, flavor, glycerin, high
fructose corn syrup, menthol, purified water.
saccharin sodium, sodium benzoate.

Package Label

AP SAFE  NDC 76281-503-24

COMPARE TO THE ACTIVE
INGREDIENTS IN ROBlTUSSIN®
PEAK COLD COUGH & CHEST
CONGESTION DM*

Adult
Tussin
Cough

Dextromethorphan HBr / Guaifenesin

Cough Suppressant / Expectorant

Non-Drowsy
Cough Formula

• Controls Cough
• Helps Loosen chest
   congestion
• For Ages 12 and over

DM

4 FL OZ (118 mL)

CAUTION: DO NOT USE IF IMPRINTED SEAL UNDER
CAP IS BROKEN OR MISSING.

3
1013430
3/20

'This product is not manufactured or distributed
by Pfizer, owner of the registered trademark
Robitussin® Peak Cold.

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

AP-BX-02

Carton

503-24 Box503-24 Box

Bottle

503-24 Btl503-24 Btl

res

TUSSIN COUGH  EXPECTORANT COUGH SUPRESSANT DM
dextromethorphan hydrobromide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76281-503
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 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)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GLYCERIN (UNII: PDC6A3C0OX)  
HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)  
MENTHOL (UNII: L7T10EIP3A)  
WATER (UNII: 059QF0KO0R)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
Product Characteristics
ColorredScore    
ShapeSize
FlavorFRUIT PUNCHImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76281-503-24118 mL in 1 BOTTLE; Type 0: Not a Combination Product09/30/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01209/30/2020
Labeler - AptaPharma Inc. (790523323)
Registrant - AptaPharma Inc. (790523323)
Establishment
NameAddressID/FEIBusiness Operations
AptaPharma Inc.790523323manufacture(76281-503)

Revised: 12/2023
Document Id: 5b440237-78c8-458a-b365-8b77ae10fdd3
Set id: 8a4c55d0-c472-4e89-9fdb-17ecf0af4856
Version: 5
Effective Time: 20231230
 
AptaPharma Inc.