CHILDRENS ACETAMINOPHEN- acetaminophen suspension 
Major Pharmaceuticals

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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Children's Acetaminophen Oral Suspension
Ibuprofen Free/Alcohol Free/Aspirin Free

Drug Facts

Active ingredient                                                                                 
(in each 5 mL)  

Acetaminophen 160 mg

Purpose

Pain reliever/fever reducer

Uses

temporarily:

Warnings

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

• more than 5 doses in 24 hours, which is the maximum daily amount
• with other drugs containing acetaminophen

Allergy alert: acetaminophen may cause severe skin reactions.

Symptoms may include:
• skin reddening
• blisters
• rash

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

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 your child has liver disease.

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

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

Stop use and ask a doctor if:
• pain gets worse or lasts more than 5 days
• fever gets worse or lasts more than 3 days
• new symptoms occur
• redness or swelling is present

These could be signs of a serious condition.

Keep out of the reach of children.

Overdose warning: 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 children even if you do not notice any sign or symptoms

Directions

Weight (lb)Age (yr)Dose (mL) *
Under 24Under 2Ask a doctor
24-352-3 years5 mL 
36-474-5 years7.5 mL 
48-596-8 years10 mL 
60-719-10 years12.5 mL 
72-9511 years15 mL 

*or as directed by a doctor

Other information

Inactive ingredients:

Acesulfame K, butylparaben, citric acid, FD&C Red No. 40, flavoring, glycerin, high fructose corn syrup, polysorbate 80, propylene glycol, purified water, sodium benzoate, sorbitol solution, veegum and xanthan gum.

Questions or comments?

Call 1-800-845-8210.

R08/22

Distributed by:

MAJOR® PHARMACEUTICALS

Indianapolis, IN 46268


PRINCIPAL DISPLAY PANEL - 5 mL Unit Dose Cup

MAJOR®

0904-7278-41

Children's Acetaminophen Oral Suspension

160 mg per 5 mL

Pain Reliever • Fever Reducer

Ibuprofen Free/ Alcohol Free / Aspirin Free

SHAKE WELL

Delivers 5 mL • See insert

For Institutional Use Only

 MAJOR® PHARMACEUTICALS

 Indianapolis, IN 46268

A1781C050882

 

5 mL Unit Dose Cup Label
CHILDRENS ACETAMINOPHEN 
acetaminophen suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-7278(NDC:0121-1781)
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
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
BUTYLPARABEN (UNII: 3QPI1U3FV8)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GLYCERIN (UNII: PDC6A3C0OX)  
HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SORBITOL SOLUTION (UNII: 8KW3E207O2)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Product Characteristics
ColorredScore    
ShapeSize
FlavorBERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0904-7278-7010 in 1 CASE06/02/2023
110 in 1 TRAY
1NDC:0904-7278-415 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34306/02/2023
Labeler - Major Pharmaceuticals (191427277)
Registrant - PAI Holdings, LLC dba Pharmaceutical Associates, Inc. (044940096)

Revised: 6/2023
Document Id: 7e52855c-5d09-4731-b312-ced4f99e4113
Set id: 38b839b6-de7d-4f33-a19a-efc92cdad92c
Version: 13
Effective Time: 20230602
 
Major Pharmaceuticals