DailyMed - DailyMed Details

Drug Facts

Composition & Product

Active Ingredients

Acetaminophen (160 mg)

Inactive Ingredients

Anhydrous Citric Acid Silicon Dioxide Copovidone K25-31 Crospovidone (120 .mu.m) D&c Red No. 27 D&c Red No. 30 Dextrose Monohydrate Ethylcellulose (4 Mpa.s) Magnesium Stearate Mannitol Sodium Starch Glycolate Type A Potato Stearic Acid Sucralose

Identifiers & Packaging

Pill Appearance

Imprint: F8 Shape: round Color: pink Size: 16 mm Score: 2

Marketing Status

OTC MONOGRAPH DRUG Active Since 2023-11-15

Medication Information

Purpose

Pain reliever/fever reducer

Description

Active ingredient (in each tablet) Acetaminophen USP 160 mg

Uses

temporarily relieves minor aches and pains due to:
- the common cold
- flu
- headache
- 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:

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.

Directions

this product does not contain directions or complete warnings for adult use.
do not give more than directed (see overdose warning)
chew tablets completely before swallowing; do not swallow tablets whole
find right dose on chart below. If possible, use weight to dose; otherwise, use age
repeat dose every 4 hours while symptoms last
do not give more than 5 times in 24 hours

Weight (lb)	Age (yr)	Dose (tablets)*
under 24	under 2 years	ask a doctor
24 to 35	2 to 3 years	1 tablet
36 to 47	4 to 5 years	1½ tablets
48 to 59	6 to 8 years	2 tablets
60 to 71	9 to 10 years	2½ tablets
72 to 95	11 years	3 tablets

*or as directed by a doctor

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

Drug Facts

Active ingredient (in each tablet)

Acetaminophen USP 160 mg

Other Information

store between 20° to 25°C (68° to 77°F). Avoid high humidity. Protect from light.
do not use if carton is open or if printed seal on blister is broken or missing.

Inactive Ingredients

citric acid anhydrous, colloidal silicon dioxide, copovidone, crospovidone, D&C red No. 27 lake, D&C red 30 aluminum lake, dextrose monohydrate, ethylcellulose, flavor, magnesium stearate, mannitol, sodium starch glycolate, stearic acid, sucralose.

Questions Or Comments?

call 1-855-274-4122

DISTRIBUTED BY:

BETTER LIVING BRANDS LLC

P.O.BOX 99 PLEASANTON,

CA 94566-0009

^‡1-888-723-3929

Made in India

Code: TS/DRUGS/16/2014

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:In case of overdose, get medical help or contact a Poison Control Center right away. (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.

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.

Package Label Principal Display Panel 160 Mg (24 Chewable Tablets Blister Carton Label)

Signature

care _®

Quality

Guaranteed

Compare to the

Children's Tylenol ^®

Chewables

active ingredient ^**

NDC 21130-223-76

AGES 2-11

DO NOT USE WITH OTHER MEDICINES

CONTAINING ACETAMINOPHEN

Childrens’s

Pain Relief

Acetaminophen Chewable Tablets 160 mg

Pain Reliever/Fever Reducer

• Aspirin Free

• Ibuprofen Free

BUBBLE GUM

Flavor

Actual Size

24 CHEWABLE TABLETS

160 mg each

Structured Label Content

Uses

temporarily relieves minor aches and pains due to:
- the common cold
- flu
- headache
- sore throat
- toothache
temporarily reduces fever

Purpose

Pain reliever/fever reducer

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.

Directions

this product does not contain directions or complete warnings for adult use.
do not give more than directed (see overdose warning)
chew tablets completely before swallowing; do not swallow tablets whole
find right dose on chart below. If possible, use weight to dose; otherwise, use age
repeat dose every 4 hours while symptoms last
do not give more than 5 times in 24 hours

Weight (lb)	Age (yr)	Dose (tablets)*
under 24	under 2 years	ask a doctor
24 to 35	2 to 3 years	1 tablet
36 to 47	4 to 5 years	1½ tablets
48 to 59	6 to 8 years	2 tablets
60 to 71	9 to 10 years	2½ tablets
72 to 95	11 years	3 tablets

*or as directed by a doctor

Do Not Use (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

Drug Facts

Active ingredient (in each tablet)

Acetaminophen USP 160 mg

Other Information (Other information)

store between 20° to 25°C (68° to 77°F). Avoid high humidity. Protect from light.
do not use if carton is open or if printed seal on blister is broken or missing.

Inactive Ingredients (Inactive ingredients)

citric acid anhydrous, colloidal silicon dioxide, copovidone, crospovidone, D&C red No. 27 lake, D&C red 30 aluminum lake, dextrose monohydrate, ethylcellulose, flavor, magnesium stearate, mannitol, sodium starch glycolate, stearic acid, sucralose.

Questions Or Comments? (Questions or comments?)

call 1-855-274-4122

DISTRIBUTED BY:

BETTER LIVING BRANDS LLC

P.O.BOX 99 PLEASANTON,

CA 94566-0009

^‡1-888-723-3929

Made in India

Code: TS/DRUGS/16/2014

Stop Use and Ask A Doctor If (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. (Keep out of reach of children.)

Overdose warning:In case of overdose, get medical help or contact a Poison Control Center right away. (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.

Ask A Doctor Before Use If Your Child Has (Ask a doctor before use if your child has)

liver disease.

Ask A Doctor Or Pharmacist Before Use If Your Child Is (Ask a doctor or pharmacist before use if your child is)

taking the blood thinning drug warfarin.

Package Label Principal Display Panel 160 Mg (24 Chewable Tablets Blister Carton Label) (PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 160 mg (24 Chewable Tablets Blister Carton Label))

Signature

care _®

Quality

Guaranteed

Compare to the

Children's Tylenol ^®

Chewables

active ingredient ^**

NDC 21130-223-76

AGES 2-11

DO NOT USE WITH OTHER MEDICINES

CONTAINING ACETAMINOPHEN

Childrens’s

Pain Relief

Acetaminophen Chewable Tablets 160 mg

Pain Reliever/Fever Reducer

• Aspirin Free

• Ibuprofen Free

BUBBLE GUM

Flavor

Actual Size

24 CHEWABLE TABLETS

160 mg each

Advanced Ingredient Data

[{"name": "ANHYDROUS CITRIC ACID", "unii": "XF417D3PSL", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SILICON DIOXIDE", "unii": "ETJ7Z6XBU4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "COPOVIDONE K25-31", "unii": "D9C330MD8B", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CROSPOVIDONE (120 .MU.M)", "unii": "68401960MK", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "D&C RED NO. 27", "unii": "2LRS185U6K", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "D&C RED NO. 30", "unii": "2S42T2808B", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DEXTROSE MONOHYDRATE", "unii": "LX22YL083G", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ETHYLCELLULOSE (4 MPA.S)", "unii": "KC5472WRJK", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MANNITOL", "unii": "3OWL53L36A", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM STARCH GLYCOLATE TYPE A POTATO", "unii": "5856J3G2A2", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STEARIC ACID", "unii": "4ELV7Z65AP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SUCRALOSE", "unii": "96K6UQ3ZD4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ACETAMINOPHEN", "unii": "362O9ITL9D", "classCode": "ACTIB", "strengthNumerator": "160", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}]

Raw Label Data

All Sections (JSON)

{"Uses": "temporarily relieves minor aches and pains due to: the common cold flu headache sore throat toothache temporarily reduces fever", "Purpose": "Pain reliever/fever reducer", "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.", "Directions": "this product does not contain directions or complete warnings for adult use. do not give more than directed (see overdose warning) chew tablets completely before swallowing; do not swallow tablets whole find right dose on chart below. If possible, use weight to dose; otherwise, use age repeat dose every 4 hours while symptoms last do not give more than 5 times in 24 hours Weight (lb) Age (yr) Dose (tablets)* under 24 under 2 years ask a doctor 24 to 35 2 to 3 years 1 tablet 36 to 47 4 to 5 years 1½ tablets 48 to 59 6 to 8 years 2 tablets 60 to 71 9 to 10 years 2½ tablets 72 to 95 11 years 3 tablets *or as directed by a doctor", "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", "Drug Facts": "Active ingredient (in each tablet) Acetaminophen USP 160 mg", "Other information": "store between 20° to 25°C (68° to 77°F). Avoid high humidity. Protect from light. do not use if carton is open or if printed seal on blister is broken or missing.", "Inactive ingredients": "citric acid anhydrous, colloidal silicon dioxide, copovidone, crospovidone, D&C red No. 27 lake, D&C red 30 aluminum lake, dextrose monohydrate, ethylcellulose, flavor, magnesium stearate, mannitol, sodium starch glycolate, stearic acid, sucralose.", "Questions or comments?": "call 1-855-274-4122 DISTRIBUTED BY: BETTER LIVING BRANDS LLC P.O.BOX 99 PLEASANTON, CA 94566-0009 ‡ 1-888-723-3929 Made in India Code: TS/DRUGS/16/2014", "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: In case of overdose, get medical help or contact a Poison Control Center right away. (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.", "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.", "PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 160 mg (24 Chewable Tablets Blister Carton Label)": "Signature care ® Quality Guaranteed Compare to the Children's Tylenol ® Chewables active ingredient ** NDC 21130-223-76 AGES 2-11 DO NOT USE WITH OTHER MEDICINES CONTAINING ACETAMINOPHEN Childrens’s Pain Relief Acetaminophen Chewable Tablets 160 mg Pain Reliever/Fever Reducer • Aspirin Free • Ibuprofen Free BUBBLE GUM Flavor Actual Size 24 CHEWABLE TABLETS 160 mg each"}