Indications and uses
temporarily reduces fever temporarily relieves minor aches and pains due to: the common cold flu headache sore throat toothache
Childrens Pain and Fever
- Manufacturer
- Lil' Drug Store Products, Inc
- Effective date
- 2018-07-12
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- legacy-cache
- Hydrated at
- 2026-08-02 00:53:31
Label at a glance#
ProductChildrens Pain and Fever Lil Drug Store Products
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; 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...
Storage and handling
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
Contacts and useful links#
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
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
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.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
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)* |
|---|---|---|
| under 24 | under 2 | ask a doctor |
| 24-35 | 2-3 | 5 mL (1 tsp) |
| 36-47 | 4-5 | 7.5 mL (1½ tsp) |
| 48-59 | 6-8 | 10 mL (2 tsp) |
| 60-71 | 9-10 | 12.5 mL (2 ½ tsp) |
| 72-95 | 11 | 15 mL (3 tsp) |
* or as directed by a doctor
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)
SPL UNCLASSIFIED SECTION
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®
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| Acetaminophen | ACTIVE INGREDIENT | 362O9ITL9D | 1 | |
| Acetaminophen | ACTIVE MOIETY | 362O9ITL9D | 1 | |
| Acesulfame potassium | INACTIVE INGREDIENT | 23OV73Q5G9 | 1 | |
| Anhydrous citric acid | INACTIVE INGREDIENT | XF417D3PSL | 1 | |
| Butylparaben | INACTIVE INGREDIENT | 3QPI1U3FV8 | 1 | |
| Carboxymethylcellulose sodium | INACTIVE INGREDIENT | K679OBS311 | 1 | |
| Cellulose, Microcrystalline | INACTIVE INGREDIENT | OP1R32D61U | 1 | |
| FD&C red no. 40 | INACTIVE INGREDIENT | WZB9127XOA | 1 | |
| Glycerin | INACTIVE INGREDIENT | PDC6A3C0OX | 1 | |
| High fructose corn syrup | INACTIVE INGREDIENT | XY6UN3QB6S | 1 | |
| Propylene Glycol | INACTIVE INGREDIENT | 6DC9Q167V3 | 1 | |
| Sodium benzoate | INACTIVE INGREDIENT | OJ245FE5EU | 1 | |
| Sorbitol | INACTIVE INGREDIENT | 506T60A25R | 1 | |
| Water | INACTIVE INGREDIENT | 059QF0KO0R | 1 | |
| Xanthan gum | INACTIVE INGREDIENT | TTV12P4NEE | 1 |
Products#
Every source-derived product name is available through these pages.
- Childrens Pain and Fever Lil Drug Store Products
- Acetaminophen
- Acesulfame potassium
- Anhydrous citric acid
- Butylparaben
- CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM
- FD&C red no. 40
- Glycerin
- High fructose corn syrup
- MICROCRYSTALLINE CELLULOSE
- Propylene Glycol
- Water
- Sodium benzoate
- Sorbitol
- Xanthan gum
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 66715-6856 | 66715-6856-4 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
Inactive ingredient matches#
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| Glycerin | GLYCERIN | PDC6A3C0OX | ELIXIR / ORAL | 5621 mg | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | INJECTION, SOLUTION / SUBCUTANEOUS | 1.4 %w/v | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | GEL / OPHTHALMIC | 0.44 %w/w | ||
| Sorbitol | SORBITOL | 506T60A25R | SUSPENSION / RECTAL | 46.18 %w/v | ||
| Sorbitol | SORBITOL | 506T60A25R | CREAM, AUGMENTED / TOPICAL | 15 %w/w | ||
| Xanthan gum | XANTHAN GUM | TTV12P4NEE | TABLET, ORALLY DISINTEGRATING / ORAL | 0.15 mg | ||
| Xanthan gum | XANTHAN GUM | TTV12P4NEE | SOLUTION, GEL FORMING, EXTENDED RELEASE / OPHTHALMIC | 0.6 %w/w | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | INJECTION / SUBCUTANEOUS | 450 mg | ||
| Sodium benzoate | SODIUM BENZOATE | OJ245FE5EU | SOLUTION / ORAL | 660 mg | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | CLOTH / TOPICAL | 0.03 mg/mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | FILM, EXTENDED RELEASE / BUCCAL | 34 mg | ||
| FD&C red no. 40 | FD&C RED NO. 40 | WZB9127XOA | TABLET, COATED / ORAL | 0.1 mg | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | AEROSOL / TOPICAL | 19.2 %w/w | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | FILM, SOLUBLE / BUCCAL | 5 mg | ||
| FD&C red no. 40 | FD&C RED NO. 40 | WZB9127XOA | CAPSULE, EXTENDED RELEASE / ORAL | 1 mg | ||
| Sorbitol | SORBITOL | 506T60A25R | SPRAY / NASAL | 49 mg | ||
| Anhydrous citric acid | ANHYDROUS CITRIC ACID | XF417D3PSL | SPRAY / NASAL | 5 mg | ||
| Sorbitol | SORBITOL | 506T60A25R | INJECTION / SUBCUTANEOUS | 4.7 %w/v | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | PASTE, DENTIFRICE / DENTAL | 18 %w/w | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | INJECTION / INTRAVENOUS | 16624 mg | ||
| Butylparaben | BUTYLPARABEN | 3QPI1U3FV8 | SOLUTION / OPHTHALMIC | 0.02 %w/w | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | CAPSULE, COATED / ORAL | 25 mg | ||
| FD&C red no. 40 | FD&C RED NO. 40 | WZB9127XOA | CAPSULE, COATED PELLETS / ORAL | NA | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | LOTION / TOPICAL | 3392 mg | ||
| Butylparaben | BUTYLPARABEN | 3QPI1U3FV8 | SYRUP / ORAL | 28.4 mg/1ml | ||
| Carboxymethylcellulose sodium | CARBOXYMETHYLCELLULOSE SODIUM | K679OBS311 | POWDER, FOR SUSPENSION / ORAL | 560 mg | ||
| Anhydrous citric acid | ANHYDROUS CITRIC ACID | XF417D3PSL | SOLUTION / TOPICAL | 4.35 %w/v | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | TABLET, COATED / ORAL | 16 mg | ||
| FD&C red no. 40 | FD&C RED NO. 40 | WZB9127XOA | CAPSULE / ORAL | 16 mg | ||
| FD&C red no. 40 | FD&C RED NO. 40 | WZB9127XOA | TABLET, CHEWABLE / ORAL | 40 mg | ||
| Sodium benzoate | SODIUM BENZOATE | OJ245FE5EU | INJECTION / INTRAVENOUS | 864 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | TABLET, COATED / ORAL | 1 mg | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | TABLET, FILM COATED / ORAL | 96 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | GEL / TRANSDERMAL | 500 mg | ||
| Acesulfame potassium | ACESULFAME POTASSIUM | 23OV73Q5G9 | TABLET, ORALLY DISINTEGRATING / ORAL | 24 mg | ||
| Anhydrous citric acid | ANHYDROUS CITRIC ACID | XF417D3PSL | TABLET, CHEWABLE, EXTENDED RELEASE / ORAL | 12 mg | ||
| Anhydrous citric acid | ANHYDROUS CITRIC ACID | XF417D3PSL | INJECTION, SOLUTION / INTRAMUSCULAR | 25 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | TABLET, CHEWABLE / ORAL | 12 mg | ||
| Sorbitol | SORBITOL | 506T60A25R | LIQUID / ORAL | 53460 mg | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | CREAM / VAGINAL | 1225 mg | ||
| Cellulose, Microcrystalline | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET / SUBLINGUAL | 43.2 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | TABLET, EXTENDED RELEASE / ORAL | 7 mg | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | CREAM / TOPICAL | 76000 mg | ||
| Sodium benzoate | SODIUM BENZOATE | OJ245FE5EU | SOLUTION / TOPICAL | 0.1 %w/v | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | DOUCHE / VAGINAL | 1 %w/w | ||
| Sorbitol | SORBITOL | 506T60A25R | GUM, CHEWING / BUCCAL | 5110 mg | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | GEL / TRANSDERMAL | 500 mg | ||
| Xanthan gum | XANTHAN GUM | TTV12P4NEE | SUSPENSION/ DROPS / ORAL | 22 mg | ||
| Butylparaben | BUTYLPARABEN | 3QPI1U3FV8 | CAPSULE, EXTENDED RELEASE / ORAL | NA | ||
| Cellulose, Microcrystalline | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, CHEWABLE / ORAL | 1725 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | CAPSULE, COATED / ORAL | 14.21 mg | ||
| FD&C red no. 40 | FD&C RED NO. 40 | WZB9127XOA | SPONGE / TOPICAL | NA | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | INJECTION, SOLUTION / INTRAVENOUS | 4000 mg | ||
| Sorbitol | SORBITOL | 506T60A25R | PASTE / DENTAL | 14.6 %w/w | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | SUSPENSION / AURICULAR (OTIC) | 0.05 %w/w | ||
| Carboxymethylcellulose sodium | CARBOXYMETHYLCELLULOSE SODIUM | K679OBS311 | SUSPENSION/ DROPS / ORAL | 12.85 mg/2.5ml | ||
| Xanthan gum | XANTHAN GUM | TTV12P4NEE | TABLET, EXTENDED RELEASE / ORAL | 528 mg | ||
| Sorbitol | SORBITOL | 506T60A25R | SYSTEM / TOPICAL | 6300 mg | ||
| Butylparaben | BUTYLPARABEN | 3QPI1U3FV8 | CAPSULE / ORAL | NA | ||
| Anhydrous citric acid | ANHYDROUS CITRIC ACID | XF417D3PSL | INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS | 35 mg |
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 |
|---|---|---|---|---|---|---|
| 681e711d-3896-442c-bfe5-701028325189 | b50ac5e7-3eb9-4e08-9e54-6c080bddee9e | 2018-07-12 | Warnings | 681e711d-3896-442c-bfe5-701028325189 b50ac5e7-3eb9-4e08-9e54-6c080bddee9e |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.