CALCIUM CARBONATE suspension

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

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Download 제품 특성 요약 (SPC)
08-11-2021

유효 성분:

CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB)

제공처:

REMEDYREPACK INC.

관리 경로:

ORAL

처방전 유형:

OTC DRUG

치료 징후:

Antacid Use for the prevention of calcium deficiency in adults.

승인 상태:

OTC monograph final

제품 특성 요약

                                CALCIUM CARBONATE- CALCIUM CARBONATE SUSPENSION
REMEDYREPACK INC.
_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._
----------
SUPPLEMENT FACTS
CALCIUM CARBONATE ORAL SUSPENSION (NOT USP)
CALCIUM SUPPLEMENT
SUPPLEMENT FACTS
SERVING SIZE: 5 ML (TEASPOONFUL)
AMOUNT PER SERVING
% DAILY VALUE
Calcium 500 mg
50 %
ACTIVE INGREDIENT
Each 5 mL (teaspoonful) delivers 1250 mg calcium carbonate (equivalent
to 500 mg
elemental calcium).
PURPOSE
Antacid
KEEP OUT OF REACH OF CHILDREN
Keep bottle tightly closed. STORE IN A COOL, DRY PLACE, OUT OF REACH
OF CHILDREN. In
case of overdose, get medical help or contact a Poison Control Center
immediately.
USES
Use for the prevention of calcium deficiency in adults.
WARNINGS
Do not use more than directed.
As with any supplement, if you are pregnant or nursing a baby, contact
your healthcare
professional before use.
The seal of the package bears our name, Roxane. If the seal is broken
or our name does
not appear, do not use.
DIRECTIONS
Shake well before using. Take 5 mL (one teaspoonful) two to three
times daily with meals
or as directed by a physician.
STORAGE AND HANDLING
Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room
Temperature.] Keep from
freezing.
Sodium content: 0 mg per 5 mL
INACTIVE INGREDIENTS
Methylparaben, propylene glycol, propylparaben, purified water, sodium
hypochlorite
solution, sorbitol solution, spearmint flavor, xanthan gum.
QUESTIONS OR COMMENTS
Repackaged and Distributed By:
Remedy Repack, Inc.
625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762
DRUG: Calcium Carbonate
GENERIC: Calcium Carbonate
DOSAGE: SUSPENSION
ADMINSTRATION: ORAL
NDC: 70518-3245-0
NDC: 70518-3245-1
PACKAGING: 5 mL in 1 CUP, UNIT DOSE
OUTER PACKAGING: 10 in 1 BOX
ACTIVE INGREDIENT(S):
CALCIUM CARBONATE 1250mg in 5mL
INACTIVE INGREDIENT(S):
SORBITOL
1-PROPOXY-2-PROPANOL
XANTHAN GUM
METHYLPARABEN
SPEARMINT
SODIUM HYPOCHLOR
                                
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