Label: SAL DE UVAS PICOT- citric acid monohydrate, sodium bicarbonate granule, effervescent
- NDC Code(s): 67751-174-01
- Packager: Navajo Manufacturing Company Inc.
- This is a repackaged label.
- Source NDC Code(s): 70565-580
- 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 November 21, 2019
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- Official Label (Printer Friendly)
- Drug Facts
- Active Ingredients (in each packet)
- Uses
- Warnings
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Directions
- fully dissolve one packet in 1/2 glass of water before taking
adults 60 years and over 1 packet every 4 hours, or as directed by a doctor. Do not exceed 3 packets in 24 hours adults and children 12 to 60 years one packet every 4 hours or as directed by a doctor. Do not exceed 4 packets in 24 hours children under 12 years ask a doctor - Other information
- Inactive ingredients
- Questions or Comments?
- Package Labeling:
-
INGREDIENTS AND APPEARANCE
SAL DE UVAS PICOT
citric acid monohydrate, sodium bicarbonate granule, effervescentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:67751-174(NDC:70565-580) 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 1.9485 g SODIUM BICARBONATE (UNII: 8MDF5V39QO) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM BICARBONATE 2.485 g 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:67751-174-01 1 in 1 CARTON 09/23/2016 1 1 in 1 POUCH; 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 09/23/2016 Labeler - Navajo Manufacturing Company Inc. (091917799) Establishment Name Address ID/FEI Business Operations Navajo Manufacturing Company Inc. 136941411 relabel(67751-174) , repack(67751-174)