NDC | 11673-719-34 |
Set ID | d610bf3b-b615-4eb5-b124-0bf0ddc58acd |
Category | HUMAN OTC DRUG LABEL |
Packager | Target Corporation |
Generic Name | |
Product Class | Antihistamine |
Product Number | |
Application Number | PART341 |
- Active ingredients (in each 20 mL)
- 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
- Ask a doctor or pharmacist before use if you are
- When using this product
- Stop use and ask a doctor if
- If pregnant or breast-feeding,
- Keep out of reach of 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?
-
Package/Label Principal Display Panel
see new dosing
Compare to active ingredients in Robitussin® Maximum Strength Nighttime Cough DM
maximum strength
nighttime cough control DM MAX
dextromethorphan HBr (cough suppressant)
doxylamine succinate (antihistamine)
relieves cough, itchy throat and runny nose
for adults
AGES 12 + YEARS
8 FL OZ (237 mL)
-
INGREDIENTS AND APPEARANCE
UP AND UP NIGHTTIME COUGH CONTROL DM MAX
dextromethorphan hbr, doxylamine succinate solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11673-719 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:11673-719-34 1 in 1 CARTON 09/26/2018 1 237 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 09/26/2018 Labeler - Target Corporation (006961700)