Label: ROBITUSSIN NIGHTTIME COUGH DM SOFT CHEWS- dextromethorphan hydrobromide, doxylamine succinate tablet, chewable
- NDC Code(s): 0031-9311-20
- Packager: Haleon US Holdings LLC
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated February 29, 2024
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- ACTIVE INGREDIENT
- PURPOSE
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INDICATIONS & USAGE
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
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 is chronic such as occurs with smoking, asthma, or chronic bronchitis or emphysema
When using this product
- 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
- DOSAGE & ADMINISTRATION
- STORAGE AND HANDLING
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INACTIVE INGREDIENT
Inactive ingredients
carboxymethylcellulose calcium, carnauba wax, corn syrup solids, crospovidone, D&C red no. 30 aluminum lake, FD&C blue no. 1 aluminum lake, glycerin, mannitol, natural and artificial flavors, pregelatinized starch, simethicone, sodium gluconate, sorbitol, sorbitol solution, sucralose, sucrose, whole dry milk
- QUESTIONS
-
Additional Information
Do Not Use if seal under bottle cap imprinted with
“SEALED for YOUR PROTECTION” is broken or missing.
PARENTS:
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Distributed by: Haleon, Warren, NJ 07059
Trademarks are owned by or licensed to the Haleon group of companies.
Pat. Info www.productpats.com
©2023 Haleon group of companies or its licensor.
For most recent product information, visit www.robitussin.com
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PRINCIPAL DISPLAY PANEL
NEW! ADULT HALEON
Robitussin
Nighttime Cough DM
Soft CHEWS
DEXTROMETHORPHAN HBr 15 mg
(Cough Suppressant)DOXYLAMINE SUCCINATE 6.25 mg
(Antihistamine)
FAST relief ANYWHERE
Cough, runny nose & sneezing
UP TO 8HRCOUGH RELIEF
20 CHEWABLE TABLETS
Chew tablets completely before swallowing
Berry flavor
208797 Front Label
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INGREDIENTS AND APPEARANCE
ROBITUSSIN NIGHTTIME COUGH DM SOFT CHEWS
dextromethorphan hydrobromide, doxylamine succinate tablet, chewableProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0031-9311 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 DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE 6.25 mg Inactive Ingredients Ingredient Name Strength CARBOXYMETHYLCELLULOSE CALCIUM (UNII: UTY7PDF93L) CARNAUBA WAX (UNII: R12CBM0EIZ) CORN SYRUP (UNII: 9G5L16BK6N) CROSPOVIDONE, UNSPECIFIED (UNII: 2S7830E561) D&C RED NO. 30 (UNII: 2S42T2808B) ALUMINUM OXIDE (UNII: LMI26O6933) GLYCERIN (UNII: PDC6A3C0OX) MANNITOL (UNII: 3OWL53L36A) STARCH, CORN (UNII: O8232NY3SJ) DIMETHICONE (UNII: 92RU3N3Y1O) SODIUM GLUCONATE (UNII: R6Q3791S76) SORBITOL (UNII: 506T60A25R) SORBITOL SOLUTION (UNII: 8KW3E207O2) SUCRALOSE (UNII: 96K6UQ3ZD4) SUCROSE (UNII: C151H8M554) COW MILK (UNII: 917J3173FT) Product Characteristics Color purple (darker purple speckles) Score no score Shape ROUND Size 21mm Flavor BERRY Imprint Code R Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0031-9311-20 20 in 1 BOTTLE; Type 0: Not a Combination Product 06/19/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M012 06/19/2024 Labeler - Haleon US Holdings LLC (079944263)