FIRSTCARE DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE by USpharma Ltd Drug Facts

FIRSTCARE DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE by

Drug Labeling and Warnings

FIRSTCARE DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE by is a Otc medication manufactured, distributed, or labeled by USpharma Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71594-706
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
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL)	DOXYLAMINE SUCCINATE	12.5 mg

Inactive Ingredients
Ingredient Name	Strength
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
Color	red (red to dark red)	Score	no score
Shape	ROUND	Size	20mm
Flavor	BERRY (mixed berry)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71594-706-12	30 in 1 BOTTLE; Type 0: Not a Combination Product	02/10/2022	12/29/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	02/10/2022	12/29/2023

Labeler - USpharma Ltd (080664601)

Establishment
Name	Address	ID/FEI	Business Operations
USpharma Ltd		080664601	manufacture(71594-706)

Revised: 1/2024

Document Id: 0ec6bccd-bd3e-8369-e063-6394a90abdd8

34390-5

Set id: 0bbcd796-6d71-4ca3-b03a-b07b6da4dc4b

Version: 2

Effective Time: 20240112

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