NDC | 53943-023-20 |
Set ID | e5e2af31-fc99-4f89-a632-dbb316ceba4a |
Category | Human OTC Drug Label |
Packager | DISCOUNT DRUG MART |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART341 |
- Active ingredients (in each 10 mL)
- Purposes
- Uses
- Warnings
-
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 you have
- Stop use and ask a doctor if
- If pregnant or breast-feeding,
- Keep out of reach of children.
-
Directions
- do not take more than 6 doses (12 tsp) in any 24-hour period
- measure only with dosing cup provided
- keep dosing cup with product
- mL = milliliter
- this adult product is not intended for use in children under 12 years of age
Age Dose adults and children
12 years and over10 mL
every 4 hourschildren under 12 years do not use - Other information
- Inactive ingredients
- Questions or Comments
-
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 8 FL OZ (237 mL Bottle)
DISCOUNT
drug
mart
FOOD FAIR
NDC 53943-023-20
Compare to the active ingredients in
Adult Robitussin® Peak Cold
Sugar-Free Cough + Chest
Congestion DM*
ADULT
TUSSIN
PEAK COLD
SUGAR-FREE
Cough + Chest
Congestion DM
Each 10 mL dose of oral solution contains:
20 mg - Dextromethorphan HBr, USP (Cough Suppressant)
200 mg - Guaifenesin, USP (Expectorant)
Relieves:
Cough Use Dosage
Mucus Cup Included
Specially
Formulated
for DIABETICS
DM
SUGAR-FREE
DYE-FREE
Non-Drowsy 8 FL OZ
For Ages 12 & Over (237 mL)
-
INGREDIENTS AND APPEARANCE
TUSSIN PEAK COLD SUGAR-FREE COUGH PLUS CHEST CONGESTION DM
dextromethorphan hbr, guaifenesin liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53943-023 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 20 mg in 10 mL GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 200 mg in 10 mL Inactive Ingredients Ingredient Name Strength ACESULFAME POTASSIUM (UNII: 23OV73Q5G9) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) CHERRY (UNII: BUC5I9595W) VANILLA (UNII: Q74T35078H) GLYCERIN (UNII: PDC6A3C0OX) HYDROXYETHYL CELLULOSE (5500 MPA.S AT 2%) (UNII: M825OX60H9) LEVOMENTHOL (UNII: BZ1R15MTK7) METHYLPARABEN (UNII: A2I8C7HI9T) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) POVIDONE K30 (UNII: U725QWY32X) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SODIUM BENZOATE (UNII: OJ245FE5EU) Product Characteristics Color YELLOW (A clear colorless to slightly yellow) Score Shape Size Flavor CHERRY, VANILLA Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53943-023-20 1 in 1 CARTON 04/21/2015 05/01/2022 1 237 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 FINAL part341 04/21/2015 05/01/2022 Labeler - DISCOUNT DRUG MART (047741335) Registrant - Aurohealth LLC (078728447) Establishment Name Address ID/FEI Business Operations Aurohealth LLC 078728447 MANUFACTURE(53943-023)