CHILDRENS PAIN AND FEVER  LIL DRUG STORE PRODUCTS- acetaminophen liquid 
Lil' Drug Store Products, 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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Children's Pain & Fever
Lil' Drug Store® Products

Drug Facts

Active ingredient (in each 5 mL = 1 teaspoon)

Acetaminophen 160 mg

Purpose

Pain reliever/fever reducer

Uses

  • temporarily reduces fever
  • temporarily relieves minor aches and pains due to:
    • the common cold
    • flu
    • headache
    • sore throat
    • toothache

Warnings

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.

Liver warning

This product 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

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

Directions

  • this product does not contain directions or complete warnings for adult use.
  • do not take more than directed (see overdose warning)
  • shake well before using
  • mL = milliliter; tsp = teaspoon
  • find the right dose on chart below. If possible, use weight to dose; otherwise, use age
  • use only the enclosed dosing cup designed for use with this product. Do not use any other dosing device.
  • if needed, repeat dose every 4 hours while symptoms last
  • do not give more than 5 times in 24 hours
  • do not give more than 5 days unless directed by a doctor
Weight (lb)Age (yr)Dose (mL or tsp)*
*
or as directed by a doctor
under 24under 2ask a doctor
24-352-35 mL (1 tsp)
36-474-57.5 mL (1½ tsp)
48-596-810 mL (2 tsp)
60-719-1012.5 mL (2 ½ tsp)
72-951115 mL (3 tsp)

Other information

  • each 5 mL (1 tsp) contains: sodium 2 mg
  • store between 20-25°C (68-77°F)
  • do not refrigerate
  • see bottom panel for lot number and expiration date

Inactive ingredients

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

Questions or comments?

Call toll free 1-877-507-6516 (M-F 8AM-4:30PM CST)

Product distributed by:
Lil' Drug Store Products, Inc.
1201 Continental Place NE
Cedar Rapids, IA 52402

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton

QUALITY
GUARANTEED

Compare to the Active Ingredient
in Children's Tylenol®
Oral Suspension**

Children's
Pain & Fever

Acetaminophen
Pain Reliever/Fever Reducer
160 mg per 5 mL

Oral Suspension
For ages 2-11

Cherry

4 FL OZ (118 mL)
160 mg per 5 mL

Lil'
DrugStore®

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton
CHILDRENS PAIN AND FEVER   LIL DRUG STORE PRODUCTS
acetaminophen liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66715-6856
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)  
Anhydrous citric acid (UNII: XF417D3PSL)  
Butylparaben (UNII: 3QPI1U3FV8)  
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
FD&C red no. 40 (UNII: WZB9127XOA)  
Glycerin (UNII: PDC6A3C0OX)  
High fructose corn syrup (UNII: XY6UN3QB6S)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
Propylene Glycol (UNII: 6DC9Q167V3)  
Water (UNII: 059QF0KO0R)  
Sodium benzoate (UNII: OJ245FE5EU)  
Sorbitol (UNII: 506T60A25R)  
Xanthan gum (UNII: TTV12P4NEE)  
Product Characteristics
ColorREDScore    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:66715-6856-41 in 1 CARTON12/01/201412/01/2020
1118 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 FINALpart34312/01/201412/01/2020
Labeler - Lil' Drug Store Products, Inc (093103646)

Revised: 7/2018
 
Lil' Drug Store Products, Inc