MEIJER MAXIMUM STRENGTH NIGHTTIME COUGH DM- dextromethorphan hydrobromide, doxylamine succinate solution

meijer Maximum Strength Nighttime Cough DM by

Drug Labeling and Warnings

meijer Maximum Strength Nighttime Cough DM by is a Otc medication manufactured, distributed, or labeled by MEIJER DISTRIBUTION INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients (in each 20 ml)	Purposes
Dextromethorphan HBr, USP 30 mg	Cough suppressant
Doxylamine Succinate, USP 12.5 mg	Antihistamine

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 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

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers

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

Stop use and ask a doctor if cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222.

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

• ▪ each 20 ml contains: sodium 14 mg
• ▪ store at room temperature.

Inactive ingredients

anhydrous citric acid, FD&C Red #40, flavor, menthol, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum.

Questions or comments?

1-866-467-2748

PRINCIPAL DISPLAY PANEL

meijer®

NDC: 41250-758-04

Compare to Robitussin® Maximum Strength Nighttime Cough DM active ingredient*

For Ages 12 & Over

adult nighttime cough DM

DEXTROMETHORPHAN HBr 30mg/20mL (Cough Suppressant)
DOXYLAMINE SUCCINATE 12.5mg/20mL (Antihistamine)

MAXIMUM STRENGTH

Nighttime

RELIEF OF: Cough, Itchy Throat, Runny Nose

4 FL OZ (118 mL)

*This product is not manufactured or distributed by Pfizer Inc, distributor of Robitussin.®

Maximum Strength claim based on maximum levels of active ingredient per dose.

DIST. BY MEIJER DISTRIBUTION, INC.

GRAND RAPIDS, MI 49544

www.meijer.com

MEIJER PHARAMACISTS RECOMMENDED

MONEY BACK GUARANTEE

INGREDIENTS AND APPEARANCE

MEIJER MAXIMUM STRENGTH NIGHTTIME COUGH DM 
dextromethorphan hydrobromide, doxylamine succinate solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41250-758
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)
FD&C RED NO. 40 (UNII: WZB9127XOA)
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
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	BERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41250-758-04	1 in 1 CARTON	03/14/2017
1		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	03/14/2017

Labeler - MEIJER DISTRIBUTION INC (006959555)