ACETAMINOPHEN- acetaminophen suspension 
CHAIN DRUG MARKETING ASSOCIATION INC

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Infants' Oral Suspension
Pain Reliever
Fever Reducer
Acetaminophen
Cherry Flavor

Active Ingredient                         Purpose
(in each 5 mL)

Acetaminophen 160 mg ............... Pain reliever/fever reducer

Uses temporarily:

due to:


Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if your child takes

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

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

Sore throat warning: if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or
vomiting, consult a doctor promptly.

When using this product do not exceed recommended dose (see overdose warning)

Do not use

Ask a doctor before use if your child has liver disease

Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin

Stop use and ask a doctor if

These could be signs of a serious condition.

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 1-800-222-1222. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

If possible, use weight to dose; otherwise, use age.

Other information

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

Inactive ingredients

acesulfame potassium, avicel, citric acid, FD&C red no. 40, flavor, glycerine, high fructose corn syrup, polysorbate, propylene glycol, prosweet N & AK, purified water, sodium benzoate, sucralose, sorbitol, xanthan gum

"This product is not manufactured or distributed by Johnson & Johnson, owner of the registered trademark Tylenol®

Distributed by C.D.M.A. lnc.
43157 W 9 Mile Rd
Novi, MI 48375
www.qualitychoice.com
Question: 800-935-2362

PRINCIPAL DISPLAY PANEL

image description

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ACETAMINOPHEN 
acetaminophen suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-678
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN160 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GLYCERIN (UNII: PDC6A3C0OX)  
HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
SORBITOL (UNII: 506T60A25R)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Product Characteristics
Color    Score    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63868-678-6060 mL in 1 BOTTLE; Type 0: Not a Combination Product02/01/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01302/01/2021
Labeler - CHAIN DRUG MARKETING ASSOCIATION INC (011920774)
Registrant - Seaway Pharma Inc. (117218785)
Establishment
NameAddressID/FEIBusiness Operations
Seaway Pharma Inc.117218785manufacture(63868-678)

Revised: 12/2024
Document Id: 8c4fdac0-f82f-4975-a01f-e5d1de264e24
Set id: cfc7eac3-35be-4002-b8ef-be1dfc8caf69
Version: 2
Effective Time: 20241226
 
CHAIN DRUG MARKETING ASSOCIATION INC