TUSSIN DM MAX NIGHTTIME- dextromethorphan hbr, doxylamine succinate liquid

Tussin DM Max by

Drug Labeling and Warnings

Tussin DM Max by is a Otc medication manufactured, distributed, or labeled by Wal-Mart Stores Inc, LNK International, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients (in each 20 mL)

Dextromethorphan HBr 30 mg
Doxylamine succinate 12.5 mg

Purpose

Cough suppressant
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:
  • itching of the nose or throat
  • runny nose
  • itchy, watery eyes
  • sneezing
• controls the impulse to cough to help you sleep
  

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

• a cough that occurs with too much phlegm (mucus)
• difficulty in urination due to enlargement of the prostate gland
• glaucoma
• 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 exceed recommended dosage
• marked drowsiness may occur
• avoid alcoholic drinks
• alcohol, sedatives and tranquilizers may increase drowsiness
• use caution when driving a motor vehicle or operating machinery 
• excitability may occur, especially in children
  

Stop use and ask a doctor if

cough persists more than 7 days, tends to recur, or is accompanied by a 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 (1-800-222-1222) right away.

Directions

• do not take more than 4 doses in any 24-hour period
• mL = milliliter; FL OZ = fluid ounce
• use only enclosed dosing cup designed for use with this product. Do not use any other dosing device.
  
• adults and children 12 years and over: 20 mL in dosing cup provided every 6 hours
  
• children under 12 years : do not use
  

Other information

• each 20 mL contains: sodium 14 mg
  
• store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
• see end flap for expiration date and lot number

Inactive ingredients

anhydrous citric acid, FD&C blue #1, FD&C red #40, flavors, glycerin, high fructose corn syrup, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium chloride, sodium citrate dihydrate, sucralose, sugar, xanthan gum

Questions or comments?

1-888-287-1915

Principal Display Panel

equate™

Compare to Robitussin® Maximum Strength Nighttime Cough DM Active Ingredients†

Maximum Strength

Nighttime
Tussin DM Max

Dextromethorphan HBr -
Cough Suppressant
Doxylamine Succinate -
Antihistamine

Nighttime Cough DM

Relief of:

Cough

Itchy throat

Runny nose

Ages 12 +
Alcohol-Free                Dosage cup included

8 FL OZ (237 mL)

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

TAMPER EVIDENT: DO NOT USE IF PRINTED NECK WRAP IS BROKEN OR MISSING

Satisfaction guaranteed-Or we'll replace it or give you your money back. For questions or comments or to report an undesired reaction or side effect. please call 1-888-287-1915.

DISTRIBUTED BY: Walmart Inc.,
Bentonville, AR 72716

†This product is not manufactured or distributed by Wyeth LLC, owner of the registered trademark Robitussin® Maximum Strength Nighttime Cough DM.

50844      ORG031804319

Equate 44-043

INGREDIENTS AND APPEARANCE

TUSSIN DM MAX  NIGHTTIME
dextromethorphan hbr, doxylamine succinate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49035-943
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 BLUE NO. 1 (UNII: H3R47K3TBD)
GLYCERIN (UNII: PDC6A3C0OX)
HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)
SUCRALOSE (UNII: 96K6UQ3ZD4)
SUCROSE (UNII: C151H8M554)
XANTHAN GUM (UNII: TTV12P4NEE)

Product Characteristics
Color	BROWN	Score
Shape		Size
Flavor	MENTHOL, BERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49035-943-19	1 in 1 CARTON	08/15/2018
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	08/15/2018

Labeler - Wal-Mart Stores Inc (051957769)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		967626305	MANUFACTURE(49035-943) , PACK(49035-943)