Label: ALKA-SELTZER KIDS TUMMY RELIEFCHEWS- calcium carbonate and dimethicone tablet, chewable
- NDC Code(s): 0280-0051-01
- Packager: Bayer HealthCare LLC.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Updated February 1, 2021
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- SPL UNCLASSIFIED SECTION
- Active ingredients and purpoose
- INDICATIONS & USAGE
Ask a doctor or pharmacist before use if you are presently taking a prescription drug. Antacids may interact with certain prescription drugs.
When using this product
● adults and children 12 years and over do not take more than 6 chewable tablets in a 24-hour period
● children 6 to under 12 years do not take more than 4 chewable tablets in a 24-hour period
● if pregnant, do not take more than 6 chewable tablets in 24 hours
● do not use the maximum dosage of this product for more than 2 weeks, except under the advice and supervision of a
DOSAGE & ADMINISTRATION
adults and children 12 years and over • fully chew then swallow 1 or 2 chewable tablets as symptoms occur, or as directed by a doctor.
• do not take more than 6 chewable tablets in a 24-hour period
children 6 years to under 12 years • under adult supervision, fully chew then swallow 1 chewable tablet as symptoms occur, or as directed by a doctor.
• do not take more than 4 chewable tablets in a 24-hour period
children under 6 years consult a doctor
- if pregnant, do not take more than 6 chewable tablets in 24 hours
- OTHER SAFETY INFORMATION
Inactive ingredients acacia, carmine, carnauba wax, citric acid, corn starch, corn syrup, FD&C red No.40 aluminum lake, flavors, hydrogenated coconut oil, hydrogenated vegetable oil, lecithin, maltodextrin, modified starch, potassium hydroxide, pregelatinized modified starch, propylene glycol, shellac, sodium benzoate, sorbic acid, sorbitol, sucrose, titanium dioxide, triacetin, water, white wax
- Package label 28 count
INGREDIENTS AND APPEARANCE
ALKA-SELTZER KIDS TUMMY RELIEFCHEWS
calcium carbonate and dimethicone tablet, chewable
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0280-0051 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CARBONATE 750 mg DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE 80 mg Inactive Ingredients Ingredient Name Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) TRIACETIN (UNII: XHX3C3X673) MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE) (UNII: 461P5CJN6T) WATER (UNII: 059QF0KO0R) WHITE WAX (UNII: 7G1J5DA97F) SHELLAC (UNII: 46N107B71O) ACACIA (UNII: 5C5403N26O) CORN SYRUP (UNII: 9G5L16BK6N) MALTODEXTRIN (UNII: 7CVR7L4A2D) METHYLPARABEN (UNII: A2I8C7HI9T) CARNAUBA WAX (UNII: R12CBM0EIZ) POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) FD&C RED NO. 40 (UNII: WZB9127XOA) HYDROGENATED COCONUT OIL (UNII: JY81OXM1OM) PROPYLPARABEN (UNII: Z8IX2SC1OH) SORBIC ACID (UNII: X045WJ989B) SORBITOL (UNII: 506T60A25R) Product Characteristics Color pink Score no score Shape ROUND Size 18mm Flavor FRUIT PUNCH Imprint Code HG Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0280-0051-01 28 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 03/01/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part331 03/01/2021 Labeler - Bayer HealthCare LLC. (112117283)