Indications and uses
• temporarily relieves minor aches and pains due to: • the common cold • headache • flu • sore throat • toothache • temporarily reduces fever
Premier Value Childrens Acetaminophen Melts
- Manufacturer
- Chain Drug Consortium
- Effective date
- 2015-01-16
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-05-31 22:44:19
Label at a glance#
ProductPremier Value Childrens Acetaminophen Melts
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 (see overdose warning) • find the right dose on chart. 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 tha...
Storage and handling
• store at controlled room temperature 20-25ºC (68-77ºF). 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 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
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 right away at 1-800-222-1222. Quick 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 (see overdose warning)
- find the right dose on chart. 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 years | ask a doctor |
24-35 | 2-3 years | 2 tablets |
36-47 | 4-5 years | 3 tablets |
48-59 | 6-8 years | 4 tablets |
60-71 | 9-10 years years | 5 tablets |
72-95 | 11 | 6 tablets |
Other information
- store at controlled room temperature 20-25ºC (68-77ºF). Avoid high humidity. Protect from light
- see end flap for expiration date and lot number
Inactive ingredients
citric acid, corn starch, crospovidone, D&C red 30 aluminum lake, dextrose, ethylcellulose, FD&C blue 1 aluminum lake, flavors, gelatin, maltodextrin, magnesium stearate, sucralose
Questions or comments?
1-866-467-2748
Product Packaging
NDC 68016-196-00
Compare to Children's Tylenol® Meltaways® Active Ingredient*
Premier Value
Children's
Pain Reliever
Ages 2-6
ACETAMINOPHEN
pain reliever/fever reducer
Aspirin Free/ Ibuprofen Free
GRAPE FLAVOR
30 count – 80mg each
TAMPER EVIDENT: DO NOT USE IF PRINTED 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®.
DailyMed RxNorm Mappings#
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 68016-196-00 | 2020-01-31 | C162847 | 48780-1 | 9d75b9cf-cfb9-f424-e053-dadaa90a57ce | Premier Value Children’s Pain Reliever |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68016-196-00 | Premier Value Childrens Acetaminophen Melts | 1 in 1 CARTON | TABLET, CHEWABLE | 1 | 1 | |
| 68016-196-00 | Premier Value Childrens Acetaminophen Melts | 30 in 1 BOTTLE, PLASTIC | TABLET, CHEWABLE | 30 | 1 |
DailyMed Dashboard NDC Coverage#
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 68016-196-00 | EA - Each | 68016-196 | 655f1d96-d6ad-4947-8bff-8f7b1dcb8ab0 | 1 | 2022-06-06 |
Products#
Every source-derived product name is available through these pages.
- Premier Value Childrens Acetaminophen Melts
- Acetaminophen
- CITRIC ACID MONOHYDRATE
- STARCH, CORN
- CROSPOVIDONE (15 MPA.S AT 5%)
- D&C RED NO. 30
- DEXTROSE, UNSPECIFIED FORM
- ETHYLCELLULOSES
- FD&C BLUE NO. 1
- GELATIN
- MALTODEXTRIN
- MAGNESIUM STEARATE
- SUCRALOSE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 68016-196 | 68016-196-00 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| CITRIC ACID MONOHYDRATE | 2968PHW8QP | IACT |
| STARCH, CORN | O8232NY3SJ | IACT |
| CROSPOVIDONE (15 MPA.S AT 5%) | 68401960MK | IACT |
| D&C RED NO. 30 | 2S42T2808B | IACT |
| DEXTROSE, UNSPECIFIED FORM | IY9XDZ35W2 | IACT |
| ETHYLCELLULOSES | 7Z8S9VYZ4B | IACT |
| FD&C BLUE NO. 1 | H3R47K3TBD | IACT |
| GELATIN | 2G86QN327L | IACT |
| MALTODEXTRIN | 7CVR7L4A2D | IACT |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| SUCRALOSE | 96K6UQ3ZD4 | IACT |
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 |
|---|---|---|---|---|---|---|
| 37aed983-2698-42f6-aa66-36022462c488 | 37aed983-2698-42f6-aa66-36022462c488 | 2015-01-16 | Warnings | 37aed983-2698-42f6-aa66-36022462c488 37aed983-2698-42f6-aa66-36022462c488 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.