ACETAMINOPHEN- acetaminophen syrup 
CHAIN DRUG MARKETING ASSOCIATION INC.

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.

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Active Ingredient                         Purpose

(In each 15 mL)

in Acetaminophen 500 mg............. Pain reliever/fever reducer

Uses

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

if skin reaction occurs, stop use and seek medical help right away.

Do not use

  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • if your child is allergic to acetaminophen or any of the inactive ingredients in this product.

Ask a doctor before use if you have 

liver disease.

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin.

Stop use and ask a doctor if

These could be signs of a serious condition.

If pregnant or breast-feeding, ask a health professional before use

Keep out of reach of children.

Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away.

Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

Other information

Questions or comments
1-800-935-2362 (Mon-Fri 9am-5pm EST)

Inactive ingredients

citric acid, D&C red #33, FD&C red #40, flavor, high fructose corn syrup, polyethylene glycol, propylene glycol, purified water, saccharin sodium,
sodium benzoate, sorbitol

Distributed by C.D.M.A, Inc.©
43157 W 9 Mile Rd
Novi, MI 48375
www.qualitychoice.com

PRINCIPAL DISPLAY PANEL

containerlabel

ACETAMINOPHEN 
acetaminophen syrup
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-809
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg  in 15 mL
Inactive Ingredients
Ingredient NameStrength
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    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63868-809-08237 mL in 1 BOTTLE; Type 0: Not a Combination Product07/01/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34307/01/2023
Labeler - CHAIN DRUG MARKETING ASSOCIATION INC. (011920774)
Registrant - Seaway Pharma Inc. (117218785)
Establishment
NameAddressID/FEIBusiness Operations
Seaway Pharma Inc.117218785manufacture(63868-809)

Revised: 7/2023
Document Id: c7469728-7e7b-48f0-9909-ac6f3943c38f
Set id: 1608b4f0-bf20-4024-b8f2-20a4df7a4b21
Version: 1
Effective Time: 20230715
 
CHAIN DRUG MARKETING ASSOCIATION INC.