Label: ROBITUSSIN HONEY MAXIMUM STRENGTH NIGHTTIME COUGH DM- dextromethorphan hbr, doxylamine succinate solution
- NDC Code(s): 0031-8758-12, 0031-8758-18
- Packager: Haleon US Holdings LLC
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated May 1, 2024
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- Official Label (Printer Friendly)
- Active ingredients (in each 20 mL)
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Uses
- temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
- temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
- runny nose
- sneezing
- itchy, watery eyes
- itching of the nose or throat
- controls the impulse to cough to help you sleep
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Warnings
Do not use
- to sedate a child or to make a child sleepy
- 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
- trouble urinating due to an enlarged prostate gland
- glaucoma
- a cough that occurs with too much phlegm (mucus)
- a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema
When using this product
- do not use more than directed
- marked drowsiness may occur
- avoid alcoholic drinks
- alcohol, sedatives, and tranquilizers may increase drowsiness
- be careful when driving a motor vehicle or operating machinery
- excitability may occur, especially in children
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Directions
- measure only with dosing cup provided
- keep dosing cup with product
- mL = milliliter
- do not take more than 4 doses in any 24-hour period
- this adult product is not intended for use in children under 12 years of age
age dose adults and children
12 years and over
20 mL every 6 hours
children under 12 years
do not use
- Other information
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Inactive ingredients
anhydrous citric acid, blueberry juice concentrate, carboxymethylcellulose sodium, glycerin, lactic acid, natural and artificial flavors, natural grade A honey, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate, sodium gluconate, sucralose, xanthan gum, zinc gluconate
- Questions or comments?
- SPL UNCLASSIFIED SECTION
-
Additional Information
Packaged with Tamper-Evident bottle cap. Do Not Use if breakable ring is
separated or missing.
Dist. by: Haleon, Warren, NJ 07059
©2024 Haleon or licensor.
Trademarks owned or licensed by Haleon.
For most recent product information,
visit www.robitussin.com
Pat. Info www.productpats.com
Made in Canada
PARENTS:
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- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ROBITUSSIN HONEY MAXIMUM STRENGTH NIGHTTIME COUGH DM
dextromethorphan hbr, doxylamine succinate solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0031-8758 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 30 mg in 20 mL DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE 12.5 mg in 20 mL Inactive Ingredients Ingredient Name Strength ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311) GLYCERIN (UNII: PDC6A3C0OX) LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT) HONEY (UNII: Y9H1V576FH) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR) SODIUM GLUCONATE (UNII: R6Q3791S76) SUCRALOSE (UNII: 96K6UQ3ZD4) XANTHAN GUM (UNII: TTV12P4NEE) ZINC GLUCONATE (UNII: U6WSN5SQ1Z) Product Characteristics Color Score Shape Size Flavor BERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0031-8758-12 1 in 1 CARTON 06/25/2018 1 118 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package 2 NDC:0031-8758-18 1 in 1 CARTON 06/25/2018 2 237 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M012 06/25/2018 Labeler - Haleon US Holdings LLC (079944263)
