Страна: США
мова: англійська
Джерело: NLM (National Library of Medicine)
CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB, CARBONATE ION - UNII:7UJQ5OPE7D)
PINNACLE PHARMA LLC
ORAL
OTC DRUG
Antacid Relieves: - heartburn - acid indigestion - sour stomach - upset stomach associated with these symptoms
OTC monograph final
CALCIUM CARBONATE- CALCIUM CARBONATE SUSPENSION PINNACLE PHARMA LLC _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._ ---------- CALCIUM CARBONATE _DRUG FACTS_ ACTIVE INGREDIENT (IN EACH 5 ML TEASPOONFUL) Calcium Carbonate 1250 mg (Equivalent to 500 mg elemental Calcium) PURPOSE Antacid USES Relieves: heartburn acid indigestion sour stomach upset stomach associated with these symptoms WARNINGS ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE taking a prescription drug. Antacids may interact with certain prescription drugs. WHEN USING THIS PRODUCT, do not take more than 6 teaspoonfuls (30 mL) in a 24- hour period or use the maximum dosage for more than 2 weeks. KEEP OUT OF REACH OF CHILDREN. DIRECTIONS SHAKE WELL BEFORE USING. Take 1 to 2 teaspoonfuls (5 to 10 mL) as symptoms occur, or as directed by a doctor. OTHER INFORMATION store at 20° - 25°C (68° - 77°F) do not freeze Calcium Carbonate Oral Suspension is a pink-colored, bubble gum flavored suspension supplied in the following oral dosage forms: NDC 0121-0766-16: 16 fl oz (473 mL) bottle NDC 0121-4766-05: 5 mL unit dose cup, in a tray of ten cups. INACTIVE INGREDIENTS calcium saccharin, citric acid, D&C Red No. 33, FD&C Red No. 40, flavoring, glycerin, methylparaben, propylene glycol, propylparaben, purified water, sorbitol and xanthan gum. QUESTIONS OR COMMENTS? Call 1-800-845-8210. You may also report serious side effects to this phone number. MANUFACTURED BY _Pharmaceutical Associates, Inc. _Greenville, SC 29605 R07/20 PRINCIPAL DISPLAY PANEL - 5 ML CUP TRAY LABEL NDC 81646-112-05 Calcium Carbonate Oral Suspension Maximum Strength 1250 mg/5 mL (equivalent to 500 mg of elemental Calcium) SUGAR FREE/ ALCOHOL FREE/ SODIUM FREE ANTACID – SHAKE WELL USUAL DOSAGE: See attached Drug Facts This unit-dose package is not child-resistant. Store at 20° - 25°C (68° - 77°F) 10 x 5 mL Unit-Dose Cups Pinn Прочитайте повний документ