Label: DOUBLE TUSSIN INTENSE COUGH RELIEVER DM- dextromethorphan hydrobromide / guaifenesin liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 10956-674-01, 10956-674-04, 10956-674-08 - Packager: Reese Pharmaceutical Co
- Category: HUMAN OTC DRUG LABEL
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated January 26, 2011
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- INDICATIONS & USAGE
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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 - ASK DOCTOR
- STOP USE
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
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DOSAGE & ADMINISTRATION
Directions
• Adults and children 12 years of age and over:
take 1 tablet every 4 hours as needed
• Children 6 to 10 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)
- PURPOSE
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
DOUBLE TUSSIN INTENSE COUGH RELIEVER DM
dextromethorphan hydrobromide / guaifenesin liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10956-674 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 5 mL Guaifenesin (UNII: 495W7451VQ) (Guaifenesin - UNII:495W7451VQ) Guaifenesin 300 mg in 5 mL Inactive Ingredients Ingredient Name Strength POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A) SODIUM BENZOATE (UNII: OJ245FE5EU) SORBITOL (UNII: 506T60A25R) Product Characteristics Color red Score Shape Size Flavor CHERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10956-674-01 1 in 1 CARTON 1 NDC:10956-674-04 120 mL in 1 BOTTLE, PLASTIC 2 NDC:10956-674-08 240 mL in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 08/02/2011 Labeler - Reese Pharmaceutical Co (004172052) Registrant - Reese Pharmaceutical Co (004172052) Establishment Name Address ID/FEI Business Operations Reese Pharmaceutical Co 004172052 relabel, repack