Label: ACETAMINOPHEN syrup
- NDC Code(s): 63868-809-08
- Packager: CHAIN DRUG MARKETING ASSOCIATION INC.
- Category: HUMAN OTC DRUG LABEL
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 July 15, 2023
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient Purpose
- PURPOSE
- Uses
-
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
- more than 4,000 mg of acetaminophen in 24 hours
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day while using this product
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
- skin reddening
- blisters
- rash
if skin reaction occurs, stop use and seek medical help right away.
- STOP USE
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
- OVERDOSAGE
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Directions
- do not take more than directed (see Overdose warning)
- do not take more than 4 doses in any 24-hour period
- measure only with dosing cup provided. Do not use any other dosing device.
- mL=milliliter
- keep dosing cup with product
- adults and children 12 years and over
- 30 mL every 6 hours while symptoms last
- do not take more than 10 days unless directed by a doctor
- children under 12 years: do not use
- Other information
- Inactive ingredients
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SPL UNCLASSIFIED SECTION
- TAMPER EVIDENT: Do not use if the safety seal around or under the cap is broken or missing
- *Compare to Active Ingredient in Tylenol® Extra Strength*
- *This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Extra Strength Tylenol®
Distributed by C.D.M.A, Inc.©
43157 W 9 Mile Rd
Novi, MI 48375
www.qualitychoice.com - PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ACETAMINOPHEN
acetaminophen syrupProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63868-809 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 500 mg in 15 mL Inactive Ingredients Ingredient Name Strength CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) D&C RED NO. 33 (UNII: 9DBA0SBB0L) FD&C RED NO. 40 (UNII: WZB9127XOA) HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) SORBITOL (UNII: 506T60A25R) SACCHARIN SODIUM (UNII: SB8ZUX40TY) Product Characteristics Color Score Shape Size Flavor CHERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63868-809-08 237 mL in 1 BOTTLE; Type 0: Not a Combination Product 07/01/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 07/01/2023 Labeler - CHAIN DRUG MARKETING ASSOCIATION INC. (011920774) Registrant - Seaway Pharma Inc. (117218785) Establishment Name Address ID/FEI Business Operations Seaway Pharma Inc. 117218785 manufacture(63868-809)