RAZZMATAZZ ANTACID: Package Insert and Label Information

RAZZMATAZZ ANTACID- calcium carbonate tablet, chewable
Provision Medical Products

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

UseS

For the relief of-Sour Stomach, Upset Stomach, Heartburn, Acid Indigestion

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.

Prompt medical attention is critical for adults as

well as for children, even if you do not notice any signs

or symptoms.

Warnings:

Ask a doctor or health professional before use if you are:

currently taking a prescription drug. Antacids may react

with certain prescription drugs.

Directions:Do not use more thsn directed. Adults and children 12 years or older.

Take 2 tablets every 4 to 6 hours or as needed,

do not exceed 18 tablets in 24 hours, or as

directed by a doctor.

Children under 12 years-Do not give to children under 12 years unless directed by a doctor.

Inactive Ingredients:

corn startch, FD&C Red 40, flavor,

magnesium stearate,

silicon dioxide, startch,

sucrose

ACTIVE INGREDIENT-calcium carbonate 420 MG

ANTACID

RASPBERRY ANTACID BOX
(click image for full-size original)

RAZZMATAZZ ANTACID
calcium carbonate tablet, chewable
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:69103-2516
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CALCIUM CARBONATE (CALCIUM CATION) CALCIUM CARBONATE 420 mg
Inactive Ingredients
Ingredient Name Strength
SUCROSE
SILICON DIOXIDE
D&C YELLOW NO. 10
FD&C BLUE NO. 1
MAGNESIUM STEARATE
STARCH, CORN
Product Characteristics
Color white (WHITE WITH GREEN FLECKS) Score no score
Shape ROUND Size 12mm
Flavor Imprint Code FR14
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69103-2516-5 250 PACKET in 1 CARTON contains a PACKET
1 2 TABLET, CHEWABLE in 1 PACKET This package is contained within the CARTON (69103-2516-5)
2 NDC:69103-2516-6 100 PACKET in 1 CARTON contains a PACKET
2 2 TABLET, CHEWABLE in 1 PACKET This package is contained within the CARTON (69103-2516-6)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part331 03/31/2015
Labeler — Provision Medical Products (036936831)
Registrant — Provision Medical Products (036936831)
Establishment
Name Address ID/FEI Operations
Ultraseal Corporation 085752004 pack (69103-2516)
Establishment
Name Address ID/FEI Operations
ULTRAtab Laboratories, Inc. 151051757 manufacture (69103-2516)

Revised: 10/2019 Provision Medical Products

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