Indications and uses
temporarily relieves minor aches and pains due to: headache sore throat flu toothache the common cold temporarily reduces fever
Childrens Chewable
- Manufacturer
- Salado Sales, Inc. | LNK International, Inc.
- Effective date
- 2021-11-03
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 6
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 22:29:07
Label at a glance#
ProductChildrens Chewable
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 or crush tablets completely before swallowing; do not swallow tablets whole 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 ...
Storage and handling
store at 25°C (77°F); 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 chewable tablet)
Acetaminophen 160 mg
Purpose
Pain reliever/fever reducer
Uses
- temporarily relieves minor aches and pains due to:
- headache
- sore throat
- flu
- toothache
- the common cold
- 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 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
- 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 or crush tablets completely before swallowing; do not swallow tablets whole
- 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 (chewable tablets)* |
| Under 24 | Under 2 | Ask a doctor |
| 24-35 | 2-3 | 1 tablet |
| 36-47 | 4-5 | 1 1/2 tablets |
| 48-59 | 6-8 | 2 tablets |
| 60-71 | 9-10 | 2 1/2 tablets |
| 72-95 | 11 | 3 tablets |
*or as directed by a doctor
Other information
- store at 25°C (77°F); 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, flavor, magnesium stearate, mannitol, polyethylene, stearic acid, sucralose
Questions or comments?
1-800-426-9391
Principal display panel
CVP®
HEALTH
COMPARE TO
CHILDREN'S TYLENOL®
ACTIVE INGREDIENT†
AGES 2-11
CHILDREN'S
CHEWABLE
ACETAMINOPHEN 160 mg
CHEWABLE TABLETS
PAIN RELIEVER/FEVER REDUCER
IBUPROFEN FREE/ASPIRIN FREE
12 CHEWABLE
TABLETS
Chew or crush tablets
completely before swallowing.
TAMPER EVIDENT: DO NOT USE IF
IMPRINTED SAFETY SEAL UNDER CAP
IS BROKEN OR MISSING
†This product is not manufactured or distributed by Johnson & Johnson
Corporation, owner of the registered trademark Children's Tylenol®.
50844 REV1018A45002
Distributed by Consumer Value Products, Inc.
P.O. Box 6115, Temple, Texas 76502
CVPproducts.com
Products#
Every source-derived product name is available through these pages.
- Childrens Chewable
- Acetaminophen
- CITRIC ACID MONOHYDRATE
- CROSPOVIDONE
- D&C RED NO. 27 ALUMINUM LAKE
- D&C RED NO. 30
- DEXTROSE MONOHYDRATE
- ETHYLCELLULOSE, UNSPECIFIED
- MAGNESIUM STEARATE
- MANNITOL
- HIGH DENSITY POLYETHYLENE
- STEARIC ACID
- SUCRALOSE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 57243-450 | 57243-450-02 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| CITRIC ACID MONOHYDRATE | 2968PHW8QP | IACT |
| CROSPOVIDONE | 2S7830E561 | IACT |
| D&C RED NO. 27 ALUMINUM LAKE | ZK64F7XSTX | IACT |
| D&C RED NO. 30 | 2S42T2808B | IACT |
| DEXTROSE MONOHYDRATE | LX22YL083G | IACT |
| ETHYLCELLULOSE, UNSPECIFIED | 7Z8S9VYZ4B | IACT |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| MANNITOL | 3OWL53L36A | IACT |
| HIGH DENSITY POLYETHYLENE | UG00KM4WR7 | IACT |
| STEARIC ACID | 4ELV7Z65AP | 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 |
|---|---|---|---|---|---|---|
| 6f47178b-52a4-42d5-99a9-3b8db341b137 | 68bf7084-0aeb-4d2d-882e-4da576c70aee | 2021-11-03 | Warnings | 68bf7084-0aeb-4d2d-882e-4da576c70aee |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.