Label: TUSSIN COUGH EXPECTORANT COUGH SUPRESSANT DM- dextromethorphan hydrobromide liquid
- NDC Code(s): 76281-503-24
- Packager: AptaPharma Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 30, 2023
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
-
WARNINGS
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 DOCTOR
- STOP USE
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
-
DOSAGE & ADMINISTRATION
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
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children under 12 years do not use
_________________________________________ - OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
-
Package Label
AP SAFE NDC 76281-503-24
COMPARE TO THE ACTIVE
INGREDIENTS IN ROBlTUSSIN®
PEAK COLD COUGH & CHEST
CONGESTION DM*Adult
Tussin
CoughDextromethorphan HBr / Guaifenesin
Cough Suppressant / Expectorant
Non-Drowsy
Cough Formula• Controls Cough
• Helps Loosen chest
congestion
• For Ages 12 and overDM
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 08110AP-BX-02
Carton
Bottle
res
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INGREDIENTS AND APPEARANCE
TUSSIN COUGH EXPECTORANT COUGH SUPRESSANT DM
dextromethorphan hydrobromide liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76281-503 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 10 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) 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 Color red Score Shape Size Flavor FRUIT PUNCH Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:76281-503-24 118 mL in 1 BOTTLE; Type 0: Not a Combination Product 09/30/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M012 09/30/2020 Labeler - AptaPharma Inc. (790523323) Registrant - AptaPharma Inc. (790523323) Establishment Name Address ID/FEI Business Operations AptaPharma Inc. 790523323 manufacture(76281-503)