Label: COUGH RELIEF COUGH SUPPRESSANT- dextromethorphan hbr liquid
- NDC Code(s): 63868-957-04
- Packager: QUALITY CHOICE (Chain Drug Marketing Association)
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Updated November 8, 2019
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- Active ingredient (in each 5 mL)
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
- chronic cough that lasts as occurs with smoking, asthma, or emphysema
- cough that occurs with too much phlegm (mucus)
Stop use and ask a doctor if
cough lasts more than 7 days, comes back, or occurs with fever, rash or headache that lasts. These could be signs of a serious condition.
- take recommended dosage or as directed by a doctor
- measure only with dosing cup provided. Do not use any other dosing device
- keep dosing cup with product
- shake well before using
- mL = milliliter
age dose adults and children 12 years and over 10 mL every 6-8 hours no to exceed 4 doses in 24 hours children 6 to 11 years of age 5 mL every 6-8 hours not to exceed 4 doses in 24 hours children under 6 years of age do not use
- Other information
- Inactive ingredients
- Questions or comments?
Principal Display Panel
Dextromehtorphan HBr 15 mg
For Ages 6 & Over
6-8 Hour Relief
FL OZ (mL)
Contains no fever reducer or pain reliever
TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF PRINTED SAFETY SEAL AROUND BOTTLE OR UNDER CAP IS BROKEN OR MISSING.
Distributed by C.D.M.A., Inc,©
43157 W. Nine Mile
Novi, MI 48376-0995
- Package Label
INGREDIENTS AND APPEARANCE
COUGH RELIEF COUGH SUPPRESSANT
dextromethorphan hbr liquid
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63868-957 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 15 mg in 5 mL Inactive Ingredients Ingredient Name Strength ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) EDETATE DISODIUM (UNII: 7FLD91C86K) GLYCERIN (UNII: PDC6A3C0OX) HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) SUCRALOSE (UNII: 96K6UQ3ZD4) SUCROSE (UNII: C151H8M554) XANTHAN GUM (UNII: TTV12P4NEE) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) HYDROXYETHYL CELLULOSE (1500 MPA.S AT 1%) (UNII: L605B5892V) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) Product Characteristics Color Score Shape Size Flavor ORANGE Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63868-957-04 1 in 1 BOX 07/31/2015 1 118 mL 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 FINAL part341 07/31/2015 Labeler - QUALITY CHOICE (Chain Drug Marketing Association) (011920774) Registrant - P & L Development, LLC (079765031)