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NDC 71594-0706-12 FIRSTCARE DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE 30; 12.5 mg/1; mg/1 Details

FIRSTCARE DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE 30; 12.5 mg/1; mg/1

FIRSTCARE DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE is a ORAL TABLET, CHEWABLE in the HUMAN OTC DRUG category. It is labeled and distributed by USpharma Ltd. The primary component is DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE.

Product Information

NDC	71594-0706
Product ID	71594-706_d7adbbe1-e7fd-3a12-e053-2995a90a35e1
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	FIRSTCARE DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE
Proprietary Name Suffix	n/a
Non-Proprietary Name	dextromethorphan hydrobromide, doxylamine succinate
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET, CHEWABLE
Route	ORAL
Active Ingredient Strength	30; 12.5
Active Ingredient Units	mg/1; mg/1
Substance Name	DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE
Labeler Name	USpharma Ltd
Pharmaceutical Class	Antihistamine [EPC], Histamine Receptor Antagonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part341
Listing Certified Through	2023-12-31

Package

Package Images

NDC 71594-0706-12 (71594070612)

Pricing Information	N/A
NDC Package Code	71594-706-12
Billing NDC	71594070612
Package	30 TABLET, CHEWABLE in 1 BOTTLE (71594-706-12)
Marketing Start Date	2022-02-10
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 0bbcd796-6d71-4ca3-b03a-b07b6da4dc4b Details

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

INGREDIENTS AND APPEARANCE

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	30 mg
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL)	DOXYLAMINE SUCCINATE	12.5 mg

Ingredient Name	Strength
Inactive Ingredients
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)
STARCH, CORN (UNII: O8232NY3SJ)
MANNITOL (UNII: 3OWL53L36A)
CARNAUBA WAX (UNII: R12CBM0EIZ)
SUCROSE (UNII: C151H8M554)

Product Characteristics
Color	red (red to dark red)	Score	no score
Shape	ROUND	Size	20mm
Flavor	BERRY (mixed berry)	Imprint Code
Contains

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

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	02/10/2022

Labeler - USpharma Ltd (080664601)

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

Revised: 2/2022

Document Id: d7adbbe1-e7fd-3a12-e053-2995a90a35e1

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

Version: 1

Effective Time: 20220210