Major 44-450-children

Drug Facts

Composition & Product

Active Ingredients

Acetaminophen (160 mg)

Inactive Ingredients

Crospovidone, Unspecified D&c Red No. 27 D&c Red No. 30 Ethylcellulose, Unspecified Magnesium Stearate Mannitol Stearic Acid Sucralose Dextrose Monohydrate Citric Acid Monohydrate High Density Polyethylene

Identifiers & Packaging

Pill Appearance

Imprint: 44;450 Shape: round Color: pink Size: 16 mm Score: 2

Marketing Status

OTC MONOGRAPH DRUG Active Since 2005-02-25

Medication Information

Purpose

Pain reliever/fever reducer

Description

Acetaminophen 160 mg

Uses

•
temporarily relieves minor aches and pains due to:
- o
  headache
- o
  sore throat
- o
  flu
- o
  toothache
- o
  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.

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

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

Other Information

•
TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
•
avoid high humidity
•
store at 25ºC (77ºF); excursions permitted between 15°-30°C (59°-86°F)
•
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?

(800) 616-2471

Principal Display Panel

MAJOR^®

NDC 71205-322-24

Children's

Māpap®

ACETAMINOPHEN

160 mg Chewable Tablets

Pain reliever / Fever reducer

ASPIRIN FREE • IBUPROFEN FREE

AGES

2-11

Chew or crush tablets completely before swallowing.

24 Chewable Tablets,

160 mg EACH

Bubble Gum Flavor

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

Distributed by MAJOR® PHARMACEUTICALS

17177 N Laurel Park Drive, Suite 233

Livonia, MI 48152 USA M-17

Relabeled by PROFICIENT RX LP

Thousand Oaks, CA 91320

Rev. 11/18

Re-order No. 700846

50844 REV1018B45008

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.

Ask A Doctor Before Use If Your Child Has

liver disease.

Active Ingredient (in Each Chewable Tablet)

Acetaminophen 160 mg

Ask A Doctor Or Pharmacist Before Use If Your Child Is

taking the blood thinning drug warfarin.

Structured Label Content

Uses

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

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

Other Information (Other information)

•
TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
•
avoid high humidity
•
store at 25ºC (77ºF); excursions permitted between 15°-30°C (59°-86°F)
•
see end flap for expiration date and lot number

Inactive Ingredients (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? (Questions or comments?)

(800) 616-2471

Principal Display Panel

MAJOR^®

NDC 71205-322-24

Children's

Māpap®

ACETAMINOPHEN

160 mg Chewable Tablets

Pain reliever / Fever reducer

ASPIRIN FREE • IBUPROFEN FREE

AGES

2-11

Chew or crush tablets completely before swallowing.

24 Chewable Tablets,

160 mg EACH

Bubble Gum Flavor

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

Distributed by MAJOR® PHARMACEUTICALS

17177 N Laurel Park Drive, Suite 233

Livonia, MI 48152 USA M-17

Relabeled by PROFICIENT RX LP

Thousand Oaks, CA 91320

Rev. 11/18

Re-order No. 700846

50844 REV1018B45008

When Using This Product (When using this product)

do not exceed recommended dosage.

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.)

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.

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

liver disease.

Active Ingredient (in Each Chewable Tablet) (Active ingredient (in each chewable tablet))

Acetaminophen 160 mg

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.

Advanced Ingredient Data

[{"name": "ACETAMINOPHEN", "unii": "362O9ITL9D", "classCode": "ACTIB", "strengthNumerator": "160", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "CROSPOVIDONE, UNSPECIFIED", "unii": "2S7830E561", "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": "ETHYLCELLULOSE, UNSPECIFIED", "unii": "7Z8S9VYZ4B", "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": "STEARIC ACID", "unii": "4ELV7Z65AP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SUCRALOSE", "unii": "96K6UQ3ZD4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DEXTROSE MONOHYDRATE", "unii": "LX22YL083G", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CITRIC ACID MONOHYDRATE", "unii": "2968PHW8QP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HIGH DENSITY POLYETHYLENE", "unii": "UG00KM4WR7", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "• temporarily relieves minor aches and pains due to: o headache o sore throat o flu o toothache o the common cold • 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 • 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", "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", "Other information": "• TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN • avoid high humidity • store at 25ºC (77ºF); excursions permitted between 15°-30°C (59°-86°F) • 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?": "(800) 616-2471", "Principal Display Panel": "MAJOR ® NDC 71205-322-24 Children's Māpap® ACETAMINOPHEN 160 mg Chewable Tablets Pain reliever / Fever reducer ASPIRIN FREE • IBUPROFEN FREE AGES 2-11 Chew or crush tablets completely before swallowing. 24 Chewable Tablets, 160 mg EACH Bubble Gum Flavor TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING Distributed by MAJOR® PHARMACEUTICALS 17177 N Laurel Park Drive, Suite 233 Livonia, MI 48152 USA M-17 Relabeled by PROFICIENT RX LP Thousand Oaks, CA 91320 Rev. 11/18 Re-order No. 700846 50844 REV1018B45008", "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.", "Ask a doctor before use if your child has": "liver disease.", "Active ingredient (in each chewable tablet)": "Acetaminophen 160 mg", "Ask a doctor or pharmacist before use if your child is": "taking the blood thinning drug warfarin."}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information