Indications and uses
temporarily reduces fever temporarily relieves minor aches and pains due to: the common cold headache flu sore throat toothache
Childrens Pain Relief
- Manufacturer
- CVS Pharmacy | LNK International, Inc.
- Effective date
- 2017-09-26
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 9
- Source
- legacy-cache
- Hydrated at
- 2026-08-02 01:11:50
Label at a glance#
ProductChildrens Pain Relief
Active ingredientACETAMINOPHEN
Label structure9 sections
Dosage and administration
do not give more than directed (see overdose warning) 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...
Storage and handling
store at 25ºC (77ºF); excursions permitted between 15°-30°C (59°-86°F) avoid high humidity protect from light 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 reduces fever
- temporarily relieves minor aches and pains due to:
- the common cold
- headache
- flu
- 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
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.
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
- do not give more than directed (see overdose warning)
- 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
- protect from light
- 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, 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
♥CVS Health™
Compare to the active ingredient
in Children's Tylenol® Meltaways®†
Rapid Tabs
NDC 59779-452-01
Children's
Pain Relief
ACETAMINOPHEN, 80 mg
Pain reliever, Fever reducer
Ages 2-6
• Aspirin free
• Ibuprofen free
30 TABLETS
Grape Flavor
Actual Product Size on Side Panel
TAMPER EVIDENT: DO NOT USE IF IMPRINTED
SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
†This product is not manufactured or distributed by McNeil
Consumer Healthcare, owner of the registered trademark
Children's Tylenol® Meltaways®.
50844 ORG101345201
Distributed by:
CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
© 2015 CVS/pharmacy CVS.com®
1-800-SHOP CVS V-11112
Product Linked Resources#
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| Barcode | EAN-13 | 0050428384404 | GTIN-13: 0050428384404 EAN-13: 0050428384404 GTIN-12: 050428384404 UPC-A: 050428384404 GTIN storage (14 digits): 00050428384404 | cvs-44-452-1.jpg |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 59779-452-01 | EA - Each | 59779-452 | 37d005ed-8158-4e4d-957a-156c830ce551 | 1 | 2022-06-06 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| ACETAMINOPHEN | ACTIVE INGREDIENT | 362O9ITL9D | 7 | |
| ACETAMINOPHEN | ACTIVE MOIETY | 362O9ITL9D | 7 | |
| CITRIC ACID MONOHYDRATE | INACTIVE INGREDIENT | 2968PHW8QP | 7 | |
| D&C RED NO. 27 | INACTIVE INGREDIENT | 2LRS185U6K | 7 | |
| D&C RED NO. 30 | INACTIVE INGREDIENT | 2S42T2808B | 7 | |
| ETHYLCELLULOSES | INACTIVE INGREDIENT | 7Z8S9VYZ4B | 7 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | 7 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | 7 | |
| MANNITOL | INACTIVE INGREDIENT | 3OWL53L36A | 7 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | 7 | |
| SUCRALOSE | INACTIVE INGREDIENT | 96K6UQ3ZD4 | 7 |
Products#
Every source-derived product name is available through these pages.
- Childrens Pain Relief
- Acetaminophen
- CITRIC ACID MONOHYDRATE
- D&C RED NO. 27
- D&C RED NO. 30
- ETHYLCELLULOSE, UNSPECIFIED
- FD&C BLUE NO. 1
- MAGNESIUM STEARATE
- MANNITOL
- STEARIC ACID
- SUCRALOSE
- CROSPOVIDONE, UNSPECIFIED
- DEXTRATES
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 59779-452 | 59779-452-01 |
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 | 2LRS185U6K | IACT |
| D&C RED NO. 30 | 2S42T2808B | IACT |
| ETHYLCELLULOSE, UNSPECIFIED | 7Z8S9VYZ4B | IACT |
| FD&C BLUE NO. 1 | H3R47K3TBD | IACT |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| MANNITOL | 3OWL53L36A | IACT |
| STEARIC ACID | 4ELV7Z65AP | IACT |
| SUCRALOSE | 96K6UQ3ZD4 | IACT |
| CROSPOVIDONE, UNSPECIFIED | 2S7830E561 | IACT |
| DEXTRATES | G263MI44RU | 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 |
|---|---|---|---|---|---|---|
| MANNITOL | MANNITOL | 3OWL53L36A | POWDER, FOR SOLUTION / ORAL | 3767 mg | ||
| SUCRALOSE | SUCRALOSE | 96K6UQ3ZD4 | FILM / ORAL | 1 mg | ||
| MANNITOL | MANNITOL | 3OWL53L36A | SOLUTION/ DROPS / OPHTHALMIC | 4.6 %w/v | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | POWDER / TOPICAL | 104 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | CAPSULE, EXTENDED RELEASE / ORAL | 1 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | INJECTION / INTRASYNOVIAL | ADJ PH | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | POWDER, FOR SOLUTION / ORAL | 315 mg | ||
| MANNITOL | MANNITOL | 3OWL53L36A | INJECTION, SOLUTION / INTRAVENOUS | 15400 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | INSERT / VAGINAL | 69 mg | ||
| MANNITOL | MANNITOL | 3OWL53L36A | TABLET / BUCCAL | 360 mg | ||
| SUCRALOSE | SUCRALOSE | 96K6UQ3ZD4 | TABLET, FOR SUSPENSION / ORAL | 65 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | INJECTION / SOFT TISSUE | ADJ PH | ||
| MANNITOL | MANNITOL | 3OWL53L36A | WAFER / ORAL | 642 mg | ||
| D&C RED NO. 27 | D&C RED NO. 27 | 2LRS185U6K | TABLET, EXTENDED RELEASE / ORAL | 1.43 mg | ||
| MANNITOL | MANNITOL | 3OWL53L36A | SOLUTION, CONCENTRATE / INTRAVENOUS | 220 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | EMULSION / TOPICAL | NA | ||
| MANNITOL | MANNITOL | 3OWL53L36A | TABLET / ORAL | 3391 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS | 608 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, FILM COATED / ORAL | 96 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | SUSPENSION, EXTENDED RELEASE / ORAL | 71 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SOLUTION / INTRAMUSCULAR | 0.05 %w/v | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | POWDER, FOR SOLUTION / ORAL | 0.04 mg/5ml | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | GRANULE, FOR SUSPENSION / ORAL | 14 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SUSPENSION, EXTENDED RELEASE / ORAL | 140.8 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, EXTENDED RELEASE / ORAL | 173 mg | ||
| MANNITOL | MANNITOL | 3OWL53L36A | TABLET, ORALLY DISINTEGRATING / SUBLINGUAL | 10.25 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 120 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | TABLET / SUBLINGUAL | 24 mg | ||
| SUCRALOSE | SUCRALOSE | 96K6UQ3ZD4 | FILM, SOLUBLE / ORAL | 33 mg | ||
| MANNITOL | MANNITOL | 3OWL53L36A | SOLUTION, GEL FORMING / DROPS / OPHTHALMIC | 4 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | LIQUID / ORAL | NA | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, FOR SUSPENSION / ORAL | 131 mg | ||
| MANNITOL | MANNITOL | 3OWL53L36A | INJECTION / INTRAVENOUS | 15200 mg | ||
| MANNITOL | MANNITOL | 3OWL53L36A | CONCENTRATE / INTRAVENOUS | 220 mg | ||
| MANNITOL | MANNITOL | 3OWL53L36A | SOLUTION / ORAL | 869 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | IMPLANT / SUBCUTANEOUS | 0.5 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET, CHEWABLE / ORAL | 180 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | FILM, SOLUBLE / ORAL | 0.04 mg | ||
| D&C RED NO. 30 | D&C RED NO. 30 | 2S42T2808B | TABLET, CHEWABLE / ORAL | 3 mg | ||
| MANNITOL | MANNITOL | 3OWL53L36A | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAMUSCULAR | 113 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SOLUTION / IONTOPHORESIS | 0.02 %w/v | ||
| SUCRALOSE | SUCRALOSE | 96K6UQ3ZD4 | SPRAY, METERED / NASAL | 2 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | INJECTION, SOLUTION, CONCENTRATE / IRRIGATION | 1 mg | ||
| SUCRALOSE | SUCRALOSE | 96K6UQ3ZD4 | SUSPENSION / ORAL | 383 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | ELIXIR / ORAL | NA | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | INJECTION, SOLUTION / INTRA-ARTICULAR | ADJ PH | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | TABLET / ORAL | 27.53 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 53 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | TROCHE / ORAL | 12 mg | ||
| MANNITOL | MANNITOL | 3OWL53L36A | POWDER, FOR SUSPENSION / ORAL | 7093 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | PELLET / ORAL | 24 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | INHALANT / ORAL | 0.08 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | INJECTION, SOLUTION, CONCENTRATE / INTRAOCULAR | 1 mg | ||
| MANNITOL | MANNITOL | 3OWL53L36A | SUSPENSION/ DROPS / OPHTHALMIC | 3.3 %w/v | ||
| MANNITOL | MANNITOL | 3OWL53L36A | TABLET, FILM COATED / ORAL | 2309 mg | ||
| MANNITOL | MANNITOL | 3OWL53L36A | GRANULE / ORAL | 1328 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | INJECTION / INTRAMUSCULAR | 28 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | INJECTION / SUBCUTANEOUS | 28 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | GEL / TOPICAL | 1 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, CHEWABLE, EXTENDED RELEASE / ORAL | 9 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 |
|---|---|---|---|---|---|---|
| bc2b7b17-94ad-4db7-8727-d1c4fbdbf19a | e616d9c8-6e0e-9d6e-bd7a-bf14cf6780ec | 2017-09-26 | Warnings | bc2b7b17-94ad-4db7-8727-d1c4fbdbf19a e616d9c8-6e0e-9d6e-bd7a-bf14cf6780ec |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.