Indications and uses
temporarily relieves minor aches and pains due to: headache the common cold flu toothache sore throat temporarily reduces fever
Childrens Chewable Pain Reliever
- Manufacturer
- L.N.K. International, Inc. | LNK International, Inc.
- Effective date
- 2018-01-25
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 8
- Source
- legacy-cache
- Hydrated at
- 2026-08-02 01:04:16
Label at a glance#
ProductChildrens Chewable Pain Reliever
Active ingredientACETAMINOPHEN
Label structure9 sections
Dosage and administration
this product does not contain directions or complete warnings for adult use do not give more than directed 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 d...
Storage and handling
Phenylketonurics: Contains Phenylalanine 6 mg per tablet store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF) 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:
- headache
- the common cold
- flu
- toothache
- sore throat
- 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:
- 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.
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
- this product does not contain directions or complete warnings for adult use
- do not give more than directed
- 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
- Phenylketonurics: Contains Phenylalanine 6 mg per tablet
- store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
- avoid high humidity
- see end flap for expiration date and lot number
Inactive ingredients
corn starch, D&C red #27 aluminum lake, D&C red #30 aluminum lake, ethylcellulose, flavor, magnesium stearate, mannitol, NutraSweet (aspartame), polyethylene, stearic acid
Questions or comments?
Call 1-800-426-9391
Principal Display Panel
QUALITY
+ PLUS
NDC 50844-185-08
†Compare to the active ingredient in Children's Tylenol® Meltaways®
Children's Chewable
PAIN RELIEVER
Acetaminophen 80 mg
PAIN RELIEVER /
FEVER REDUCER
• Ibuprofen Free • Aspirin Free • Fruit Flavored
24
Tablets
AGES 2-6
ACTUAL SIZE
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 REV0416B18508
Distributed by
LNK INTERNATIONAL, INC.
60 Arkay Drive, Hauppauge, NY 11788
USA
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| ACETAMINOPHEN | ACTIVE INGREDIENT | 362O9ITL9D | 3 | |
| ACETAMINOPHEN | ACTIVE MOIETY | 362O9ITL9D | 3 | |
| ASPARTAME | INACTIVE INGREDIENT | Z0H242BBR1 | 3 | |
| D&C RED NO. 27 | INACTIVE INGREDIENT | 2LRS185U6K | 3 | |
| D&C RED NO. 30 | INACTIVE INGREDIENT | 2S42T2808B | 3 | |
| ETHYLCELLULOSES | INACTIVE INGREDIENT | 7Z8S9VYZ4B | 3 | |
| MANNITOL | INACTIVE INGREDIENT | 3OWL53L36A | 3 |
Products#
Every source-derived product name is available through these pages.
- Childrens Chewable Pain Reliever
- Acetaminophen
- D&C RED NO. 27
- D&C RED NO. 30
- ASPARTAME
- MANNITOL
- ETHYLCELLULOSES
- STARCH, CORN
- MAGNESIUM STEARATE
- STEARIC ACID
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 50844-185 | 50844-185-08 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| D&C RED NO. 27 | 2LRS185U6K | IACT |
| D&C RED NO. 30 | 2S42T2808B | IACT |
| ASPARTAME | Z0H242BBR1 | IACT |
| MANNITOL | 3OWL53L36A | IACT |
| ETHYLCELLULOSES | 7Z8S9VYZ4B | IACT |
| STARCH, CORN | O8232NY3SJ | IACT |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| STEARIC ACID | 4ELV7Z65AP | 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 | INJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS | 181 mg | ||
| ASPARTAME | ASPARTAME | Z0H242BBR1 | SOLUTION / ORAL | 40 mg | ||
| MANNITOL | MANNITOL | 3OWL53L36A | TABLET, CHEWABLE / ORAL | 3726 mg | ||
| MANNITOL | MANNITOL | 3OWL53L36A | SOLUTION / TOPICAL | 4 %w/v | ||
| ETHYLCELLULOSES | ETHYLCELLULOSE | 7Z8S9VYZ4B | TABLET / ORAL | 300 mg | ||
| ASPARTAME | ASPARTAME | Z0H242BBR1 | TABLET, ORALLY DISINTEGRATING / ORAL | 180 mg | ||
| ETHYLCELLULOSES | ETHYLCELLULOSE | 7Z8S9VYZ4B | POWDER / ORAL | 2090 mg | ||
| ASPARTAME | ASPARTAME | Z0H242BBR1 | TABLET, CHEWABLE / ORAL | 195 mg | ||
| ASPARTAME | ASPARTAME | Z0H242BBR1 | POWDER / ORAL | 63 mg | ||
| ETHYLCELLULOSES | ETHYLCELLULOSE | 7Z8S9VYZ4B | GRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL | 1000 mg | ||
| MANNITOL | MANNITOL | 3OWL53L36A | SUSPENSION / OPHTHALMIC | 9 mg | ||
| MANNITOL | MANNITOL | 3OWL53L36A | INJECTION, SOLUTION / SUBMUCOSAL | 2.94 %w/v | ||
| D&C RED NO. 30 | D&C RED NO. 30 | 2S42T2808B | TABLET / ORAL | 19 mg | ||
| D&C RED NO. 30 | D&C RED NO. 30 | 2S42T2808B | TABLET, COATED / ORAL | 1.16 mg | ||
| MANNITOL | MANNITOL | 3OWL53L36A | INJECTION, SUSPENSION / INTRAMUSCULAR | 71 mg | ||
| ETHYLCELLULOSES | ETHYLCELLULOSE | 7Z8S9VYZ4B | SUSPENSION, EXTENDED RELEASE / ORAL | NA | ||
| ETHYLCELLULOSES | ETHYLCELLULOSE | 7Z8S9VYZ4B | SYSTEM / TOPICAL | 10 mg | ||
| MANNITOL | MANNITOL | 3OWL53L36A | LOZENGE / ORAL | 20546 mg | ||
| MANNITOL | MANNITOL | 3OWL53L36A | GUM, CHEWING / BUCCAL | 891 mg | ||
| MANNITOL | MANNITOL | 3OWL53L36A | GRANULE, FOR SUSPENSION / ORAL | 6000 mg | ||
| ETHYLCELLULOSES | ETHYLCELLULOSE | 7Z8S9VYZ4B | CAPSULE, EXTENDED RELEASE / ORAL | 153 mg | ||
| ASPARTAME | ASPARTAME | Z0H242BBR1 | FILM, EXTENDED RELEASE / BUCCAL | 1 mg | ||
| MANNITOL | MANNITOL | 3OWL53L36A | SOLUTION, CONCENTRATE / INTRAVENOUS | 220 mg | ||
| MANNITOL | MANNITOL | 3OWL53L36A | SPRAY / NASAL | 41.5 mg | ||
| ETHYLCELLULOSES | ETHYLCELLULOSE | 7Z8S9VYZ4B | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 52.5 mg | ||
| MANNITOL | MANNITOL | 3OWL53L36A | POWDER, FOR SOLUTION / ORAL | 3767 mg | ||
| MANNITOL | MANNITOL | 3OWL53L36A | TABLET / ORAL | 3391 mg | ||
| MANNITOL | MANNITOL | 3OWL53L36A | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / SUBCUTANEOUS | 658 mg | ||
| ASPARTAME | ASPARTAME | Z0H242BBR1 | TABLET, CHEWABLE, EXTENDED RELEASE / ORAL | 18 mg | ||
| ASPARTAME | ASPARTAME | Z0H242BBR1 | TABLET, FILM COATED / ORAL | 20 mg | ||
| D&C RED NO. 30 | D&C RED NO. 30 | 2S42T2808B | CAPSULE / ORAL | 0.1 mg | ||
| ETHYLCELLULOSES | ETHYLCELLULOSE | 7Z8S9VYZ4B | TABLET, COATED / ORAL | 20 mg | ||
| MANNITOL | MANNITOL | 3OWL53L36A | INJECTION / INTRAMUSCULAR | 106.6 mg | ||
| MANNITOL | MANNITOL | 3OWL53L36A | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 543 mg | ||
| MANNITOL | MANNITOL | 3OWL53L36A | INJECTION, SOLUTION / INTRAVENOUS | 15400 mg | ||
| MANNITOL | MANNITOL | 3OWL53L36A | SUSPENSION, EXTENDED RELEASE / ORAL | 2464.6 mg | ||
| D&C RED NO. 27 | D&C RED NO. 27 | 2LRS185U6K | TABLET, CHEWABLE / ORAL | 7 mg | ||
| MANNITOL | MANNITOL | 3OWL53L36A | WAFER / ORAL | 642 mg | ||
| MANNITOL | MANNITOL | 3OWL53L36A | TABLET, FILM COATED / ORAL | 2309 mg | ||
| ETHYLCELLULOSES | ETHYLCELLULOSE | 7Z8S9VYZ4B | CREAM / TOPICAL | NA | ||
| MANNITOL | MANNITOL | 3OWL53L36A | INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR | 300 mg | ||
| MANNITOL | MANNITOL | 3OWL53L36A | CAPSULE, DELAYED RELEASE / ORAL | 2043 mg | ||
| MANNITOL | MANNITOL | 3OWL53L36A | TABLET, FOR SUSPENSION / ORAL | 7621 mg | ||
| ETHYLCELLULOSES | ETHYLCELLULOSE | 7Z8S9VYZ4B | TABLET, DELAYED RELEASE / ORAL | 53.8 mg | ||
| MANNITOL | MANNITOL | 3OWL53L36A | SOLUTION / INTRAVENOUS | 15400 mg | ||
| ASPARTAME | ASPARTAME | Z0H242BBR1 | GRANULE, EFFERVESCENT / ORAL | 30 mg | ||
| ASPARTAME | ASPARTAME | Z0H242BBR1 | POWDER, FOR SUSPENSION / ORAL | 420 mg | ||
| MANNITOL | MANNITOL | 3OWL53L36A | INJECTION, SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | 105 mg | ||
| MANNITOL | MANNITOL | 3OWL53L36A | POWDER, FOR SUSPENSION / ORAL | 7093 mg | ||
| MANNITOL | MANNITOL | 3OWL53L36A | CAPSULE / ORAL | 1562 mg | ||
| MANNITOL | MANNITOL | 3OWL53L36A | SOLUTION/ DROPS / OPHTHALMIC | 4.6 %w/v | ||
| ASPARTAME | ASPARTAME | Z0H242BBR1 | SYRUP / ORAL | 0.63 mg/5ml | ||
| MANNITOL | MANNITOL | 3OWL53L36A | SOLUTION / ORAL | 869 mg | ||
| ASPARTAME | ASPARTAME | Z0H242BBR1 | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 78 mg | ||
| ETHYLCELLULOSES | ETHYLCELLULOSE | 7Z8S9VYZ4B | CAPSULE / ORAL | 12.32 mg | ||
| MANNITOL | MANNITOL | 3OWL53L36A | CAPSULE, COATED, EXTENDED RELEASE / ORAL | NA | ||
| ETHYLCELLULOSES | ETHYLCELLULOSE | 7Z8S9VYZ4B | TABLET, EXTENDED RELEASE / ORAL | 1120 mg | ||
| D&C RED NO. 30 | D&C RED NO. 30 | 2S42T2808B | TABLET, FILM COATED / ORAL | 0.26 mg | ||
| MANNITOL | MANNITOL | 3OWL53L36A | INJECTION, SOLUTION / SUBCUTANEOUS | 99 mg | ||
| MANNITOL | MANNITOL | 3OWL53L36A | SUSPENSION/ DROPS / OPHTHALMIC | 3.3 %w/v |
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 |
|---|---|---|---|---|---|---|
| ba65fb1e-e188-490f-9fe3-770af93a6401 | c441db65-a3da-4acd-a396-1df656cac9e8 | 2018-01-25 | Warnings | ba65fb1e-e188-490f-9fe3-770af93a6401 c441db65-a3da-4acd-a396-1df656cac9e8 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.