Label: SAL DE UVAS PICOT- citric acid monohydrate and sodium bicarbonate granule, effervescent
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NDC Code(s):
73208-580-01,
73208-580-02,
73208-580-03,
73208-580-04, view more73208-580-05
- Packager: RB Health Mexico, S.A. de C.V.
- 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.
Drug Label Information
Updated December 23, 2021
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- Uses
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Warnings
Do not take more than directed in a 24-hour period or use the maximum dosage of this product more than 2 weeks, except under the advice and supervision of a physician.
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Directions
fully dissolve one packet in ½ glass (4 fl oz) of water.
Adults and children 12 to 60 years of age 1 packet every 4 hours, or as directed by a doctor Do not exceed 4 packets in 24 hours Adults 60 years of age and over 1 packet every 4 hours, or as directed by a doctor Do not exceed 3 packets in 24 hours Children under 12 years of age Ask a doctor - Other information
- Inactive ingredients
- Questions?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 4 Packet Carton
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INGREDIENTS AND APPEARANCE
SAL DE UVAS PICOT
citric acid monohydrate and sodium bicarbonate granule, effervescentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:73208-580 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Citric Acid monohydrate (UNII: 2968PHW8QP) (Anhydrous Citric Acid - UNII:XF417D3PSL) Anhydrous Citric Acid 1948.5 mg Sodium bicarbonate (UNII: 8MDF5V39QO) (BICARBONATE ION - UNII:HN1ZRA3Q20) Sodium bicarbonate 2485 mg Inactive Ingredients Ingredient Name Strength Silicon dioxide (UNII: ETJ7Z6XBU4) SUCROSE (UNII: C151H8M554) Tartaric acid (UNII: W4888I119H) Product Characteristics Color WHITE Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:73208-580-01 4 in 1 CARTON 01/07/2022 1 1 in 1 PACKET; Type 0: Not a Combination Product 2 NDC:73208-580-02 6 in 1 CARTON 01/07/2022 2 1 in 1 PACKET; Type 0: Not a Combination Product 3 NDC:73208-580-03 8 in 1 CARTON 01/07/2022 3 1 in 1 PACKET; Type 0: Not a Combination Product 4 NDC:73208-580-04 12 in 1 CARTON 01/07/2022 4 1 in 1 PACKET; Type 0: Not a Combination Product 5 NDC:73208-580-05 50 in 1 CARTON 01/07/2022 5 1 in 1 PACKET; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part331 01/07/2022 Labeler - RB Health Mexico, S.A. de C.V. (951563359)