FIRSTCARE DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE- dextromethorphan hydrobromide, doxylamine succinate tablet, chewable 
USpharma Ltd

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Drug Facts

Active ingredients (in each chewable tablet)

Dextromethorphan HBr, USP 30 mg

Doxylamine Succinate, USP 12.5 mg

Purposes

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:
  • 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.

Directions

Do not take more than the recommended dose

adults & children under 12 years and over

  • take 2 chewable tablets with water every 4 hours
  • do not exceed 10 chewable tablets in 24 hours or as directed by a doctor

children under 12 years

  • do not use

Other information

  • store in a cool dry place between 20-25°C (68-77°F).
  • Child Resistant Container;do not use if printed seal under cap is broken or missing.

Inactive ingredients

anhydrous citric acid, calcium gluconate monohydrate, carnauba wax, coconut oil, corn syrup, croscarmellose sodium, crospovidone, FD&C red no. 40, flavor, hydroxypropyl betadex, maltitol solution, mannitol, microcrystalline cellulose, noncrystallizing sorbitol solution, powered milk, sorbitol, starch, sucralose, sucrose

Questions or comments?

Call 1-800-227-6151

PRINCIPAL DISPLAY PANEL

FIRSTCARETM

***MADE IN USA***

NDC 71594-706-12

Mixed Berry Flavor

Dextromethorphan HBr and Doxylamine Succinate 30mg/12.5 mg

Fast Effective:Cough Relief

30 Chewables

SOFT CHEWS

Bottle Label

FIRSTCARE DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE 
dextromethorphan hydrobromide, doxylamine succinate tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71594-706
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE30 mg
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE12.5 mg
Inactive Ingredients
Ingredient NameStrength
COCONUT OIL (UNII: Q9L0O73W7L)  
MALTITOL (UNII: D65DG142WK)  
NONCRYSTALLIZING SORBITOL SOLUTION (UNII: 9E0S3UM200)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
SORBITOL (UNII: 506T60A25R)  
CALCIUM GLUCONATE MONOHYDRATE (UNII: CZN0MI5R31)  
HYDROXYPROPYL BETADEX (UNII: 1I96OHX6EK)  
SKIM MILK (UNII: 6A001Y4M5A)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
CORN SYRUP (UNII: 9G5L16BK6N)  
CROSPOVIDONE (UNII: 2S7830E561)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
MANNITOL (UNII: 3OWL53L36A)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
SUCROSE (UNII: C151H8M554)  
STARCH, CORN (UNII: O8232NY3SJ)  
Product Characteristics
Colorred (red to dark red) Scoreno score
ShapeROUNDSize20mm
FlavorBERRY (mixed berry) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71594-706-1230 in 1 BOTTLE; Type 0: Not a Combination Product02/10/202212/29/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01202/10/202212/29/2023
Labeler - USpharma Ltd (080664601)
Establishment
NameAddressID/FEIBusiness Operations
USpharma Ltd080664601manufacture(71594-706)

Revised: 1/2024
 
USpharma Ltd