LIL DRUG STORE INFANTS PAIN RELIEVER- acetaminophen liquid

Lil Drug Store Infants Pain Reliever by

Drug Labeling and Warnings

Lil Drug Store Infants Pain Reliever by is a Otc medication manufactured, distributed, or labeled by Lil Drug Store Products, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Drug Facts

Active ingredient (in each 5 mL)

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

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.

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 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

• 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
• only use the enclosed syringe. Do not use any other syringe, dropper, spoon or dosing device when giving this medicine to your child.
• remove cap, insert syringe into hole at top of bottle until it snaps into place and turn upside down
• pull back syringe until filled to the prescribed level. If you pass the prescribed level, invert assembly to right side up on flat surface and simply push syringe back until you have reached the desired level. Slowly dispense the liquid into your child's mouth (towards inner cheek).
• 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
• replace cap tightly to maintain child resistance
• find the right dose on chart below. If possible, use weight to dose; otherwise, use age.

Weight (lb)	Age (year)	Dose (mL)*
* or as directed by a doctor
under 24	under 2	ask a doctor
24-35	2-3	5 mL

Other information

• store between 20-25°C (68-77°F)
• do not refrigerate
• see bottom panel for lot number and expiration date

Inactive ingredients

acesulfame potassium, butylparaben, carboxymethylcellulose sodium, citric acid, 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)

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

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton

QUALITY
GUARANTEED

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

For ages 2-3 years

Infants'
Pain & Fever

Acetaminophen
160 mg per 5 mL
Oral Suspension
Pain Reliever/Fever Reducer

• Ibuprofen & Aspirin Free
• Alcohol Free

Enhanced dosing system reduces
the chance of accidental
ingestion and overdose.

Use Only Enclosed Syringe.

Cherry
Flavor

1 FL OZ (30 mL)

Lil'
Drug Store®

INGREDIENTS AND APPEARANCE

LIL DRUG STORE INFANTS PAIN RELIEVER 
acetaminophen liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66715-6857
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D)	Acetaminophen	160 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
Acesulfame Potassium (UNII: 23OV73Q5G9)
Butylparaben (UNII: 3QPI1U3FV8)
Carboxymethylcellulose Sodium, Unspecified Form (UNII: K679OBS311)
Anhydrous Citric Acid (UNII: XF417D3PSL)
Microcrystalline Cellulose (UNII: OP1R32D61U)
FD&C Red No. 40 (UNII: WZB9127XOA)
Glycerin (UNII: PDC6A3C0OX)
High Fructose Corn Syrup (UNII: XY6UN3QB6S)
Propylene Glycol (UNII: 6DC9Q167V3)
Sodium Benzoate (UNII: OJ245FE5EU)
Sorbitol (UNII: 506T60A25R)
Water (UNII: 059QF0KO0R)
Xanthan Gum (UNII: TTV12P4NEE)

Product Characteristics
Color	RED	Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66715-6857-4	1 in 1 CARTON	10/17/2017	04/08/2023
1		30 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	10/17/2017	04/08/2023

Labeler - Lil Drug Store Products, Inc (093103646)