ACETAMINOPHEN- acetaminophen suspension 
Precision Dose, Inc.
Reference Label Set Id: e1d4f562-433c-4344-9b77-1a7c731d1be5

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ACETAMINOPHEN ORAL SUSPENSION

Grape Flavor

80 mg/2.5 mL 160 mg/5 mL 325 mg/10.15 mL

650 mg/20.3 mL

For Hospital Use Only

Drug Facts

Active ingredient (in each 5 mL)

Acetaminophen 160 mg

Purpose

Pain reliever/fever reducer

Uses

temporarily:

Warnings

Liver warning

This product contains acetaminophen. Severe liver damage may occur if

  • adult takes more than 4,000 mg of acetaminophen in 24 hours
  • child takes more than 5 doses in 24 hours
  • taken with other drugs containing acetaminophen
  • adult has 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 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 has ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if your child has liver disease

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

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

Stop use and ask a doctor if

  • pain gets worse or lasts more than 10 days (for adults) or 5 days (for children)
  • 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

  • do not give this product to children for pain of arthritis unless directed by a doctor

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

Keep out of 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 for children even if you do not notice any signs or symptoms.

Directions

Weight (lb)Age (yr)Dose (mL)*
*
or as directed by a doctor
under 24under 2 yearsask 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
Over 96Adults and children 12 years and over20 mL

Other information

Inactive ingredients

anhydrous citric acid, calcium sulfate, carrageenan, D&C red #33, FD&C blue #1, flavor, glycerin, high fructose corn syrup, hydroxyethyl cellulose, microcrystalline cellulose and carboxymethylcellulose sodium, propylene glycol, purified water, sodium benzoate, sorbitol solution, tribasic sodium phosphate

Questions or comments?

1-800-397-9228

Alcohol Free, Aspirin Free, Gluten Free, Ibuprofen Free

How Supplied

NDC 68094-130-58
2.5 mL per unit dose syringe
Fifty (50) syringes per shipper

NDC 68094-231-58
5 mL per unit dose syringe
Fifty (50) syringes per shipper

NDC 68094-231-61
5 mL per unit dose cup
One hundred (100) cups per shipper

NDC 68094-231-62
5 mL per unit dose cup
Thirty (30) cups per shipper

NDC 68094-330-61
10.15 mL per unit dose cup
One hundred (100) cups per shipper

NDC 68094-330-62
10.15 mL per unit dose cup
Thirty (30) cups per shipper

NDC 68094-030-62
20.3 mL per unit dose cup
Thirty (30) cups per shipper

Packaged By
Precision Dose, Inc.
South Beloit, IL 61080

For inquiries call Precision Dose, Inc. at 1-800-397-9228 or email druginfo@precisiondose.com

LI1263 Rev. 04/23

PRINCIPAL DISPLAY PANEL - 5 mL Cup Label

NDC 68094-231-59

PrecisionDose™

ACETAMINOPHEN
Oral Suspension
160 mg/5 mL

Pkg: Precision Dose, Inc., S. Beloit, IL 61080

PRINCIPAL DISPLAY PANEL - 5 mL Cup Label

PRINCIPAL DISPLAY PANEL - 5 mL Syringe Label

Hospital Use Only

NDC# 68094 - 231-01
ACETAMINOPHEN Oral Suspension

160 m g/5 mL Delivers 5 mL
Alcohol Free Aspirin Free Ibuprofen Free
Each 5 mL contains Sodium 3 mg Gluten Free
Store at 20 °- 25 °C (68°-77 °F)
Pkg: Precision Dose, Inc. S. Beloit, IL 61080
LSY1305 Rev. 09/19

For Oral Use Only

PRINCIPAL DISPLAY PANEL - 5 mL Syringe Label
ACETAMINOPHEN 
acetaminophen suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68094-231(NDC:0113-0212)
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
anhydrous citric acid (UNII: XF417D3PSL)  
butylparaben (UNII: 3QPI1U3FV8)  
calcium sulfate, unspecified form (UNII: WAT0DDB505)  
carrageenan (UNII: 5C69YCD2YJ)  
D&C red no. 33 (UNII: 9DBA0SBB0L)  
FD&C blue no. 1 (UNII: H3R47K3TBD)  
glycerin (UNII: PDC6A3C0OX)  
high fructose corn syrup (UNII: XY6UN3QB6S)  
microcrystalline cellulose (UNII: OP1R32D61U)  
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
propylene glycol (UNII: 6DC9Q167V3)  
water (UNII: 059QF0KO0R)  
sodium benzoate (UNII: OJ245FE5EU)  
sorbitol (UNII: 506T60A25R)  
sodium phosphate, tribasic (UNII: A752Q30A6X)  
Product Characteristics
ColorPURPLE (viscous) Score    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68094-231-623 in 1 CASE04/01/2020
110 in 1 TRAY
1NDC:68094-231-595 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
2NDC:68094-231-6110 in 1 CASE04/01/2020
210 in 1 TRAY
2NDC:68094-231-595 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
3NDC:68094-231-585 in 1 CASE07/31/2023
310 in 1 BAG
3NDC:68094-231-015 mL in 1 SYRINGE, PLASTIC; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph drugM01304/01/2020
Labeler - Precision Dose, Inc. (035886746)
Establishment
NameAddressID/FEIBusiness Operations
Precision Dose, Inc.035886746REPACK(68094-231)

Revised: 1/2024
Document Id: 5997f1f8-31b3-46d5-9f34-1bb13f0fc07b
Set id: 554a7381-7f9a-4782-916a-10f9bc44b4f6
Version: 6
Effective Time: 20240108
 
Precision Dose, Inc.