Label: TOPCARE CHEST CONGESTION AND COUGH RELIEF DM- dextromethorphan hydrobromide / guaifenesin tablet
- NDC Code(s): 36800-988-50
- Packager: TOPCO ASSOCIATES LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 18, 2024
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- ASK DOCTOR
- STOP USE
-
DO NOT USE
Do not use if you are now taking a prescription monoamine oxidase (inhiMor~MAIO)
Certain drugs for depression, psychiatric or emotional conditioners or Parkinson's disease
or for 2 weeks after stopping MAIO drug, If you do not know if your prescription drug contains
an MAIO, ask your doctor or pharmacist before using this product.
- KEEP OUT OF REACH OF CHILDREN
- PREGNANCY OR BREAST FEEDING
- INACTIVE INGREDIENT
-
DOSAGE & ADMINISTRATION
Directions
• Adults and children 12 years of age and over:
take 1 tablet every 4 hours as needed
• Children 610 under 12 years of age: take 1/2 tablet every 4 hours as needed
• Children under 6 years of age: consult a doctor
Do not exceed 6 doses in a 24 hour period or as directed by a doctor
Other information store at 15'- 30' C (59'- 86'F) Rev 10/U9 RCCF
- INDICATIONS & USAGE
- PURPOSE
-
WARNINGS
Do not use if you are now taking a prescription monoamine oxidase (inhiMor~MAIO)
Certain drugs for depression, psychiatric or emotional conditioners or Parkinson's disease
or for 2 weeks after stopping MAIO drug, If you do not know if your prescription drug contains
an MAIO, ask your doctor or pharmacist before using this product.
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
TOPCARE CHEST CONGESTION AND COUGH RELIEF DM
dextromethorphan hydrobromide / guaifenesin tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:36800-988 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 Guaifenesin (UNII: 495W7451VQ) (Guaifenesin - UNII:495W7451VQ) Guaifenesin 400 mg Inactive Ingredients Ingredient Name Strength MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) COPOVIDONE (UNII: D9C330MD8B) MALTODEXTRIN (UNII: 7CVR7L4A2D) STEARIC ACID (UNII: 4ELV7Z65AP) Product Characteristics Color white Score 2 pieces Shape OVAL Size 17mm Flavor Imprint Code PH073 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:36800-988-50 1 in 1 CARTON 01/28/2010 1 30 in 1 BOTTLE, PLASTIC; 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 12/07/2009 Labeler - TOPCO ASSOCIATES LLC (006935977) Registrant - Reese Pharmaceutical Co (004172052)