NIGHTTIME COUGH DM- dextromethorphan hbr, doxylamine succinate solution 
Family Dollar Services Inc

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Family Wellness 44-043 Delisted

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
    • itchy, watery eyes
    • runny nose
    • 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)
  • glaucoma
  • difficulty in urination due to enlargement of the prostate gland
  • a breathing problem or persistent or chronic cough 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 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 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • 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?

1-800-426-9391

Principal display panel

Compare to the active ingredients in Robitussin® MAXIMUM STRENGTH Nighttime Cough DM*

FAMILY
wellness™

NDC 55319-043-36

MAXIMUM STRENGTH

Nighttime
Cough DM

Dextromethorphan HBr - Cough Suppressant
Doxylamine Succinate - Antihistamine

Relives:

Cough
Runny Nose
Sneezing

Menthol-Berry
Flavored

DM
NIGHTTIME
MAX

4 FL OZ (118 mL)

Alcohol Free

For ages 12 and over

DISTRIBUTED BY:
MIDWOOD BRANDS, LLC

500 Volvo Parkway
Chesapeake, VA 23320

NOT 100% SATISFIED
Return package and unused product
within 30 days to any Family Dollar store
for a refund (with receipt) or exchange.

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

*This product is not manufactured or
distributed by Wyeth LLC, owner of the
registered trademark Robitussin®
MAXIMUM STRENGTH Nighttime Cough DM.
50844 REV0318A04336

Family Wellness 44-043

Family Wellness 44-043

NIGHTTIME COUGH DM 
dextromethorphan hbr, doxylamine succinate solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55319-043
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE30 mg  in 20 mL
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE12.5 mg  in 20 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
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
Colorred (Maroon) Score    
ShapeSize
FlavorBERRY, MENTHOLImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55319-043-361 in 1 CARTON08/01/201902/23/2024
1118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01208/01/201902/23/2024
Labeler - Family Dollar Services Inc (024472631)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.967626305manufacture(55319-043) , pack(55319-043)

Revised: 2/2024
 
Family Dollar Services Inc