Indications and uses
temporarily reduces fever temporarily relieves minor aches and pains due to the common cold flu headache sore throat toothache
Lil Drug Store Infants Pain Reliever
- Manufacturer
- Lil Drug Store Products, Inc
- Effective date
- 2020-04-16
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 23:34:37
Label at a glance#
ProductLil Drug Store Infants Pain Reliever
Active ingredientAcetaminophen
Label structure11 sections
Dosage and administration
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 s...
Storage and handling
store between 20-25°C (68-77°F) do not refrigerate see bottom panel for lot number and expiration date
Contacts and useful links#
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
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
OTC - ASK DOCTOR SECTION
Ask a doctor before use if your child has liver disease.
OTC - ASK DOCTOR/PHARMACIST SECTION
Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin.
OTC - WHEN USING SECTION
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)* |
|---|---|---|
| under 24 | under 2 | ask a doctor |
| 24-35 | 2-3 | 5 mL |
* or as directed by a doctor
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)
SPL UNCLASSIFIED SECTION
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®
Products#
Every source-derived product name is available through these pages.
- Lil Drug Store Infants Pain Reliever
- Acetaminophen
- Acesulfame Potassium
- Butylparaben
- Carboxymethylcellulose Sodium, Unspecified Form
- Anhydrous Citric Acid
- Microcrystalline Cellulose
- FD&C Red No. 40
- Glycerin
- High Fructose Corn Syrup
- Propylene Glycol
- Sodium Benzoate
- Sorbitol
- Water
- Xanthan Gum
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 66715-6857 | 66715-6857-4 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| fa567fc4-9f87-421f-81e6-8aa064b348fb | 8fc0fa9d-9349-42d0-a6e6-8b63b119dde1 | 2020-04-16 | Warnings | fa567fc4-9f87-421f-81e6-8aa064b348fb 8fc0fa9d-9349-42d0-a6e6-8b63b119dde1 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.