ACID REDUCER- ranitidine tablet, film coated

United States - English - NLM (National Library of Medicine)

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Active ingredient:
RANITIDINE HYDROCHLORIDE (UNII: BK76465IHM) (RANITIDINE - UNII:884KT10YB7)
Available from:
NuCare Pharmaceuticals,Inc.
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Acid reducer - relieves heartburn associated with acid indigestion and sour stomach - prevents heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain foods and beverages
Authorization status:
Abbreviated New Drug Application
Authorization number:
68071-5012-3

ACID REDUCER- ranitidine tablet, film coated

NuCare Pharmaceuticals,Inc.

----------

GC765D

Active ingredient (in each tablet)

Ranitidine 75 mg (as ranitidine hydrochloride, USP 84 mg)

Purpose

Acid reducer

Uses

relieves heartburn associated with acid indigestion and sour stomach

prevents heartburn associated with acid indigestion and sour stomach brought on by eating or

drinking certain foods and beverages

Warnings

Allergy alert: Do not use if you are allergic to ranitidine or other acid reducers.

Do not use

if you have trouble or pain swallowing food, vomiting with blood, or bloody or black stools. These

may be signs of a serious condition. See your doctor.

with other acid reducers

Ask a doctor before use if you have

had heartburn over 3 months. This may be a sign of a more serious condition.

heartburn with lightheadedness, sweating or dizziness

chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or

shoulders; or lightheadedness

frequent chest pain

frequent wheezing, particularly with heartburn

unexplained weight loss

nausea or vomiting

stomach pain

Stop use and ask a doctor if

your heartburn continues or worsens

you need to take this product for more than 14 days

If pregnant or breast-feeding, ask a healthcare 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 chew tablet

swallow tablet with a glass of water

adults and children 12 years and over:

to relieve symptoms, take 1 tablet

to prevent symptoms, take 1 tablet 30 to 60 minutes before eating food or drinking beverages

that cause heartburn

can be used up to twice daily (do not take more than 2 tablets in 24 hours)

children under 12 years; ask a doctor

Other information

store at 20°C to 25°C (68°F to 77°F)

avoid excessive heat or humidity

this product is sodium and sugar free

Inactive ingredients

FD&C red #40 aluminum lake, hypromellose, iron oxide black, magnesium stearate, microcrystalline

cellulose, polyethylene glycol, titanium dioxide

Questions?

Call 1-800-540-3765

Principal Display Panel

ACID REDUCER

ranitidine tablet, film coated

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 8 0 71-50 12(NDC:578 9 6 -715)

Route of Administration

ORAL

NuCare Pharmaceuticals,Inc.

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

RANITIDINE HYDRO CHLO RIDE (UNII: BK76 46 5IHM) (RANITIDINE - UNII:8 8 4KT10 YB7)

RANITIDINE

75 mg

Inactive Ingredients

Ingredient Name

Stre ng th

HYPRO MELLO SES (UNII: 3NXW29 V3WO)

MAGNESIUM STEARATE (UNII: 70 0 9 7M6 I30 )

CELLULO SE, MICRO CRYSTALLINE (UNII: OP1R32D6 1U)

PO LYETHYLENE GLYCO L, UNSPECIFIED (UNII: 3WJQ0 SDW1A)

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

FERRO SO FERRIC O XIDE (UNII: XM0 M8 7F357)

FD&C RED NO . 4 0 (UNII: WZB9 127XOA)

Product Characteristics

Color

pink

S core

no sco re

S hap e

ROUND

S iz e

Flavor

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 8 0 71-50 12-3

30 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 8 /0 1/20 19

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

ANDA

ANDA0 7529 4

10 /0 1/20 18

Labeler -

NuCare Pharmaceuticals,Inc. (010632300)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

NuCare Pharmaceuticals,Inc.

0 10 6 3230 0

re la be l(6 8 0 71-50 12)

Revised: 8/2019

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