Indications and uses
temporarily relieves minor aches and pains due to: the common cold headache flu sore throat toothache temporarily reduces fever
Childrens Pain and Fever
- Manufacturer
- Walgreen Company | LNK International, Inc.
- Effective date
- 2018-06-07
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 6
- Source
- legacy-cache
- Hydrated at
- 2026-08-02 00:54:52
Label at a glance#
ProductChildrens Pain and Fever
Active ingredientACETAMINOPHEN
Label structure9 sections
Dosage and administration
do not give more than directed this product does not contain directions or complete warnings for adult use find the right dose on chart below. If possible, use weight to dose; otherwise, use age. chew before swallowing; this product will soften in mouth for ease of chewing repeat dose every 4 hours while symptoms last do not give more than 5 times in 24 hours do not give for more than 5 days unless directed by a ...
Storage and handling
store at 25ºC (77ºF); excursions permitted between 15°-30°C (59°-86°F) avoid high humidity see end flap for expiration date and lot number
Contacts and useful links#
Label contents#
Full prescribing information#
Active ingredient (in each tablet)
Acetaminophen 80 mg
Purpose
Pain reliever/fever reducer
Uses
- temporarily relieves minor aches and pains due to:
- the common cold
- headache
- flu
- sore throat
- toothache
- temporarily reduces fever
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:
- rash
- skin reddening
- blisters
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 dosage.
Stop use and ask a doctor if
- pain gets worse or lasts more than 5 days
- fever gets worse or lasts more than 3 days
- new symptoms occur
- redness or swelling is present
These could be signs of a serious condition.
Keep out of reach of children.
In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt medical
attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Directions
- do not give more than directed
- this product does not contain directions or complete warnings for adult use
- find the right dose on chart below. If possible, use weight to dose; otherwise, use age.
- chew before swallowing; this product will soften in mouth for ease of chewing
- repeat dose every 4 hours while symptoms last
- do not give more than 5 times in 24 hours
- do not give for more than 5 days unless directed by a doctor
| Weight (lb) | Age (yr) | Dose (tablets)* |
| Under 24 | Under 2 | Ask a doctor |
| 24-35 | 2-3 | 2 |
| 36-47 | 4-5 | 3 |
| 48-59 | 6-8 | 4 |
| 60-71 | 9-10 | 5 |
| 72-95 | 11 | 6 |
*or as directed by a doctor
Other information
- store at 25ºC (77ºF); excursions permitted between 15°-30°C (59°-86°F)
- avoid high humidity
- see end flap for expiration date and lot number
Inactive ingredients
citric acid, crospovidone, D&C red #27 aluminum lake, D&C red #30 aluminum lake, dextrates hydrated, ethylcellulose, FD&C blue #1 aluminum lake, flavors, magnesium stearate, mannitol, polyethylene, stearic acid, sucralose
Questions or comments?
1-800-426-9391
Principal Display Panel
Well at
Walgreens
WALGREENS PHARMACIST RECOMMENDEDǂ
NDC 0363-0452-01
children's
FAST-DISSOLVING
Pain & Fever
Acetaminophen 80 mg /
Pain Reliever / Fever Reducer
• Aspirin free • Ibuprofen free
• Ages 2 to 6
30 FAST-DISSOLVING
TABLETS
GRAPE FLAVOR
Compare to Children's Tylenol® Meltaways® active ingredientǂǂ
ǂWalgreens Pharmacist Survey Study, November 2014.
ǂǂThis product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Children's Tylenol® Meltaways®.
50844 REV0416B45201
DISTRIBUTED BY: WALGREEN CO.
200 WILMOT RD., DEERFIELD, IL 60015
Walgreens
100% SATISFACTION GUARANTEED
walgreens.com ©2016 Walgreen Co.
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
Product Linked Resources#
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| Barcode | EAN-13 | 0311917086019 | GTIN-13: 0311917086019 EAN-13: 0311917086019 GTIN-12: 311917086019 UPC-A: 311917086019 GTIN storage (14 digits): 00311917086019 | walgreens-44-452-1.jpg |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0363-0452-01 | EA - Each | 0363-0452 | 1b5e0d6f-6fec-4c49-aeb7-e48d7b0864e0 | 1 | 2013-10-17 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| ACETAMINOPHEN | ACTIVE INGREDIENT | 362O9ITL9D | 3 | |
| ACETAMINOPHEN | ACTIVE MOIETY | 362O9ITL9D | 3 | |
| CITRIC ACID MONOHYDRATE | INACTIVE INGREDIENT | 2968PHW8QP | 3 | |
| D&C RED NO. 27 | INACTIVE INGREDIENT | 2LRS185U6K | 3 | |
| D&C RED NO. 30 | INACTIVE INGREDIENT | 2S42T2808B | 3 | |
| ETHYLCELLULOSES | INACTIVE INGREDIENT | 7Z8S9VYZ4B | 3 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | 3 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | 3 | |
| MANNITOL | INACTIVE INGREDIENT | 3OWL53L36A | 3 | |
| POVIDONES | INACTIVE INGREDIENT | FZ989GH94E | 3 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | 3 | |
| SUCRALOSE | INACTIVE INGREDIENT | 96K6UQ3ZD4 | 3 |
Products#
Every source-derived product name is available through these pages.
- Childrens Pain and Fever
- Acetaminophen
- CITRIC ACID MONOHYDRATE
- D&C RED NO. 27 ALUMINUM LAKE
- D&C RED NO. 30
- ETHYLCELLULOSES
- FD&C BLUE NO. 1
- MAGNESIUM STEARATE
- MANNITOL
- STEARIC ACID
- SUCRALOSE
- CROSPOVIDONE
- HIGH DENSITY POLYETHYLENE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 0363-0452 | 0363-0452-01 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| CITRIC ACID MONOHYDRATE | 2968PHW8QP | IACT |
| D&C RED NO. 27 ALUMINUM LAKE | ZK64F7XSTX | IACT |
| D&C RED NO. 30 | 2S42T2808B | IACT |
| ETHYLCELLULOSES | 7Z8S9VYZ4B | IACT |
| FD&C BLUE NO. 1 | H3R47K3TBD | IACT |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| MANNITOL | 3OWL53L36A | IACT |
| STEARIC ACID | 4ELV7Z65AP | IACT |
| SUCRALOSE | 96K6UQ3ZD4 | IACT |
| CROSPOVIDONE | 2S7830E561 | IACT |
| HIGH DENSITY POLYETHYLENE | UG00KM4WR7 | IACT |
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 |
|---|---|---|---|---|---|---|
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SOLUTION / AURICULAR (OTIC) | 0.2 %w/v | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | SYRUP / ORAL | 0.05 mg/5ml | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | FILM, EXTENDED RELEASE / TRANSDERMAL | 1.38 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | AEROSOL, FOAM / TOPICAL | 1 mg | ||
| ETHYLCELLULOSES | ETHYLCELLULOSE | 7Z8S9VYZ4B | CAPSULE, EXTENDED RELEASE / ORAL | 153 mg | ||
| POVIDONES | POVIDONE | FZ989GH94E | SOLUTION / OPHTHALMIC | 1.8 %w/v | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SPRAY / NASAL | 9 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | CAPSULE, COATED, EXTENDED RELEASE / ORAL | NA | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | SOLUTION / DENTAL | NA | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SOLUTION / INTRAOCULAR | 1 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | INJECTION / INTRA-ARTICULAR | ADJ PH | ||
| SUCRALOSE | SUCRALOSE | 96K6UQ3ZD4 | POWDER, FOR SOLUTION / ORAL | 414 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | SUSPENSION, EXTENDED RELEASE / ORAL | 71 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | CAPSULE, EXTENDED RELEASE / ORAL | 64 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | LOZENGE / ORAL | 420 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | FILM / SUBLINGUAL | 0.07 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET / BUCCAL | 6 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | CAPSULE / ORAL | 238 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SOLUTION / OPHTHALMIC | 0.03 %w/v | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | CAPSULE, EXTENDED RELEASE / ORAL | 1 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | POWDER, FOR SUSPENSION / ORAL | 120 mg | ||
| D&C RED NO. 30 | D&C RED NO. 30 | 2S42T2808B | TABLET, COATED / ORAL | 1.16 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SYSTEM / IONTOPHORESIS | 0.2 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | TABLET / SUBLINGUAL | 24 mg | ||
| MANNITOL | MANNITOL | 3OWL53L36A | INJECTION, SUSPENSION / INTRAMUSCULAR | 71 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET, FILM COATED / ORAL | 176 mg | ||
| MANNITOL | MANNITOL | 3OWL53L36A | CAPSULE, EXTENDED RELEASE / ORAL | 160 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | CREAM / TOPICAL | NA | ||
| MANNITOL | MANNITOL | 3OWL53L36A | CAPSULE / ORAL | 1562 mg | ||
| MANNITOL | MANNITOL | 3OWL53L36A | INJECTION / INTRAVENOUS | 15200 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | GRANULE, FOR SUSPENSION / ORAL | 14 mg | ||
| SUCRALOSE | SUCRALOSE | 96K6UQ3ZD4 | POWDER, FOR SUSPENSION / ORAL | 400 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | TABLET, COATED / ORAL | 0.52 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SPRAY, METERED / NASAL | 2 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | SUSPENSION / ORAL | 1 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | TABLET, COATED / ORAL | NA | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | DOUCHE / VAGINAL | 0.07 %w/w | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | PASTE, DENTIFRICE / DENTAL | NA | ||
| POVIDONES | POVIDONE | FZ989GH94E | TABLET / SUBLINGUAL | 6 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET, DELAYED RELEASE / ORAL | 80 mg | ||
| D&C RED NO. 30 | D&C RED NO. 30 | 2S42T2808B | TABLET, CHEWABLE, EXTENDED RELEASE / ORAL | 1 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | LIQUID / INTRAVENOUS | 0.2 %w/v | ||
| MANNITOL | MANNITOL | 3OWL53L36A | TABLET, ORALLY DISINTEGRATING / SUBLINGUAL | 10.25 mg | ||
| POVIDONES | POVIDONE | FZ989GH94E | TABLET, CHEWABLE / ORAL | 48 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SYRUP / ORAL | 722 mg/5ml | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | LOTION / TOPICAL | 0.85 %w/w | ||
| MANNITOL | MANNITOL | 3OWL53L36A | SOLUTION/ DROPS / OPHTHALMIC | 4.6 %w/v | ||
| SUCRALOSE | SUCRALOSE | 96K6UQ3ZD4 | GRANULE, FOR SUSPENSION / ORAL | 23 mg | ||
| POVIDONES | POVIDONE | FZ989GH94E | SYSTEM / TOPICAL | 41 mg | ||
| POVIDONES | POVIDONE | FZ989GH94E | TABLET, DELAYED RELEASE / ORAL | 53 mg | ||
| MANNITOL | MANNITOL | 3OWL53L36A | POWDER / RESPIRATORY (INHALATION) | 6 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | INJECTION / INTRAVENOUS | 2068 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | GEL / TOPICAL | 1 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | TABLET, EXTENDED RELEASE / ORAL | 4 mg | ||
| MANNITOL | MANNITOL | 3OWL53L36A | POWDER, FOR SUSPENSION / INTRAMUSCULAR | 6.75 %w/v | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SOLUTION / INTRAMUSCULAR | 0.05 %w/v | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | INJECTION, SOLUTION / INTRA-ARTICULAR | ADJ PH | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, ORALLY DISINTEGRATING / ORAL | 187 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | CAPSULE, COATED PELLETS / ORAL | NA | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | TABLET / ORAL | 914 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 |
|---|---|---|---|---|---|---|
| 2bbe2404-e489-43e5-b713-afd22f7778f0 | 347fc07c-6bf3-4547-a93b-ae0e687a6364 | 2018-06-07 | Warnings | 2bbe2404-e489-43e5-b713-afd22f7778f0 347fc07c-6bf3-4547-a93b-ae0e687a6364 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.