FDA.reportPublic FDA data

FIRSTCARE DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE

Manufacturer
USpharma Ltd
Effective date
2022-02-10
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 22:08:49

Label at a glance#

ProductFIRSTCARE DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE
Label structure9 sections

Indications and 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

Dosage and administration

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

Storage and handling

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.

Label contents#

Full prescribing information#

Active ingredients (in each chewable tablet)

OTC - ACTIVE INGREDIENT SECTION

Dextromethorphan HBr, USP 30 mg

Doxylamine Succinate, USP 12.5 mg

Purposes

OTC - PURPOSE SECTION

Cough suppressant

Antihistamine

Uses

INDICATIONS & USAGE SECTION

  • 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

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

  • 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

OTC - ASK DOCTOR SECTION

  • 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

OTC - ASK DOCTOR/PHARMACIST SECTION

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

When using this product

OTC - WHEN USING SECTION

  • 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

OTC - STOP USE SECTION

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.

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

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

STORAGE AND HANDLING SECTION

  • 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

INACTIVE INGREDIENT SECTION

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?

OTC - QUESTIONS SECTION

Call 1-800-227-6151

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.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 LabelBottle Label

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 24 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71594-70671594-706-12

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

Name, UNII, Kind table
NameUNIIKind
COCONUT OILQ9L0O73W7LIACT
MALTITOLD65DG142WKIACT
NONCRYSTALLIZING SORBITOL SOLUTION9E0S3UM200IACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
SUCRALOSE96K6UQ3ZD4IACT
FD&C RED NO. 40WZB9127XOAIACT
SORBITOL506T60A25RIACT
CALCIUM GLUCONATE MONOHYDRATECZN0MI5R31IACT
HYDROXYPROPYL BETADEX1I96OHX6EKIACT
SKIM MILK6A001Y4M5AIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
CORN SYRUP9G5L16BK6NIACT
CROSPOVIDONE2S7830E561IACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
STARCH, CORNO8232NY3SJIACT
MANNITOL3OWL53L36AIACT
CARNAUBA WAXR12CBM0EIZIACT
SUCROSEC151H8M554IACT
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
DOXYLAMINE SUCCINATEV9BI9B5YI2ACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
0ec6bccd-bd3e-8369-e063-6394a90abdd80bbcd796-6d71-4ca3-b03a-b07b6da4dc4b2024-01-12WarningsExact identifier
spl set id: 0bbcd796-6d71-4ca3-b03a-b07b6da4dc4b

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.