PAIN AND FEVER RELIEF INFANTS- acetaminophen suspension 
Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)

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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Drug Facts

Active ingredient (in each 5 mL)

Acetaminophen 160 mg

Purpose

Pain reliever/fever reducer

Uses

Warnings

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

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

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

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 non prescription). 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 recommended dose (see overdose warning)

Stop use and ask a doctor if

  • new symptoms occur
  • redness or swelling is present
  • pain gets worse or lasts more than 5 days
  • fever gets worse or lasts more than 3 days

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 (1-800-222-1222) right away. Quick medical attention is critical even if you do not notice any signs or symptoms.

Directions

Weight (lb)Age (yr)  Dose (mL)
 under 24under 2 yearsask a doctor
 24-35 2-3 years5 mL

Other information

Inactive ingredients

acesulfame potassium, anhydrous citric acid, butylparaben, carboxymethylcellulose sodium, FD&c red #40, flavors, glycerin, high fructose corn syrup, microcrystalline celllulose, propylene glycol, purified water, sodium benzoate, sorbitol, xanthan gum

Questions or comments?

Call 1-888-309-9030

Principal Display Panel

Compare to active ingredient of Infants' Tylenol® Oral Suspension**

For Ages 2 to 3 Years

Infants'

Pain & Fever Relief

Acetaminophen

160 mg per 5 mL

Oral suspension

Pain Reliever / Fever Reducer

Enhanced dosing system reduces the chance of accidental ingestion and overdose

Use only enclosed syringe

FL OZ (mL)

CHERRY FLAVOR

**This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Infants' Tylenol® Oral Suspension.

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR PRINTED SAFETY SEAL AROUND THE BOTTLE IS BROKEN OR MISSING.

DISTRIBUTED BY DOLGENCORP, LLC

100 MISSION RIDGE

GOODLETTSVILLE, TN 37072

Package Label

Acetaminophen 160 mg

DOLLAR GENERAL HEALTH Pain & Fever Relief Cherry Flavor

PAIN AND FEVER RELIEF  INFANTS
acetaminophen suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55910-021
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
BUTYLPARABEN (UNII: 3QPI1U3FV8)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GLYCERIN (UNII: PDC6A3C0OX)  
HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SORBITOL (UNII: 506T60A25R)  
XANTHAN GUM (UNII: TTV12P4NEE)  
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
Product Characteristics
Color    Score    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55910-021-021 in 1 BOX04/30/201504/30/2025
159 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34304/30/201504/30/2025
Labeler - Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) (068331990)

Revised: 1/2023
Document Id: e7e76e9a-dd13-4c5e-bb75-ce3588ae10e5
Set id: c2abe550-8d4f-41ee-bc7e-3b7795933e32
Version: 5
Effective Time: 20230119
 
Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)