NDC | 49035-423-12, 49035-705-26, 49035-781-26 |
Set ID | 35046d3d-b42c-48cd-8d2a-d50c36114e89 |
Category | HUMAN OTC DRUG LABEL |
Packager | Wal-Mart Stores Inc |
Generic Name | |
Product Class | Antihistamine |
Product Number | |
Application Number | PART341 |
- Active ingredients (in each 20mL) - NIGHTTIME
- Purposes
-
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
-
Warnings
Do Not Use
- •
- 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
- •
- cough that occurs with too much phlegm (mucus)
- •
- a breathing problem such as emphysema or chronic bronchitis
- •
- persistent or chronic cough such as occurs with smoking, asthma, 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
-
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
- Inactive Ingredients
- Questions or comments?
- Active ingredients (in each 20 mL) - DAYTIME
- Purposes
- Uses
-
Warnings
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
- •
- cough that occurs with too much phlegm (mucus)
- •
- cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema
-
Directions
- •
- do not take more than 6 doses in any 24-hour period
- •
- measure only with dosing cup provided
- •
- keep dosing cup with product
- •
- mL = milliliter
- •
- 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 4 hours
children under 12 years
do not use
- Other information
- Inactive Ingredients
-
Package/Label Principal Display Panel
DAY & NIGHT RELIEF VALUE PACK
SEE NEW DOSING
Compare to Robitussin® Maximum Strength Cough + Chest Congestion DM Active Ingredients
Non-Drowsy/Maximum Strength
Adult
Tussin DM Max
Daytime
Cough & Chest Congestion DM
Dextromethorphan HBr – Cough Suppressant
Guaifenesin – Expectorant
Relief of:
Cough
Mucus
Chest congestion
Ages 12+
Alcohol-Free
Gluten-Free
DM MAX
Dosage cup included
Compare to Robitussin® Maximum Strength Nighttime Cough DM Active Ingredients
Maximum Strength
Adult
Tussin DM Max
Nighttime
Nighttime Cough DM
Dextromethorphan HBr – Cough Suppressant
Doxylamine Succinate – Antihistamine
Relief of:
Cough
Itchy throat
Runny nose
Ages 12+
Alcohol-Free
Gluten-Free
DM MAX
Dosage cup included
2 – 4 FL OZ (118mL) BOTTLES 8 FL OZ (236mL) TOTAL
-
INGREDIENTS AND APPEARANCE
EQUATE TUSSIN DM MAX DAYTIME NIGHTTIME
dextromethorphan hbr, doxylamine succinate, guaifenesin kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49035-423 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49035-423-12 1 in 1 CARTON; Type 0: Not a Combination Product 10/18/2018 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 BOTTLE 118 mL Part 2 1 BOTTLE 118 mL Part 1 of 2 EQUATE TUSSIN DM MAX NIGHTTIME
dextromethorphan hbr, doxylamine succinate solutionProduct Information Item Code (Source) NDC:49035-781 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) BENZOIC ACID (UNII: 8SKN0B0MIM) BENZYL ALCOHOL (UNII: LKG8494WBH) CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C RED NO. 40 (UNII: WZB9127XOA) GLYCERIN (UNII: PDC6A3C0OX) MENTHOL (UNII: L7T10EIP3A) POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) SORBITOL (UNII: 506T60A25R) SUCRALOSE (UNII: 96K6UQ3ZD4) XANTHAN GUM (UNII: TTV12P4NEE) Product Characteristics Color RED Score Shape Size Flavor FRUIT Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49035-781-26 118 mL in 1 BOTTLE; 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 10/18/2018 Part 2 of 2 EQUATE ADULT TUSSIN DM MAX
dextromethorphan hbr, guaifenesin solutionProduct Information Item Code (Source) NDC:49035-705 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 20 mL GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 400 mg in 20 mL Inactive Ingredients Ingredient Name Strength ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C RED NO. 40 (UNII: WZB9127XOA) GLYCERIN (UNII: PDC6A3C0OX) MENTHOL (UNII: L7T10EIP3A) POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) SODIUM CITRATE (UNII: 1Q73Q2JULR) SORBITOL (UNII: 506T60A25R) SUCRALOSE (UNII: 96K6UQ3ZD4) XANTHAN GUM (UNII: TTV12P4NEE) Product Characteristics Color RED Score Shape Size Flavor FRUIT Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49035-705-26 118 mL in 1 BOTTLE; 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 10/02/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 10/18/2018 Labeler - Wal-Mart Stores Inc (051957769)