Equaline 44-450-children

Equaline 44-450-children
SPL v12
SPL
SPL Set ID f65203a2-64f0-4138-97e4-6eab99194178
Route
ORAL
Published
Effective Date 2025-12-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (160 mg)
Inactive Ingredients
Citric Acid Monohydrate Crospovidone, Unspecified D&c Red No. 27 Aluminum Lake D&c Red No. 30 Aluminum Lake Dextrose Monohydrate Ethylcellulose, Unspecified Magnesium Stearate Mannitol High Density Polyethylene Stearic Acid Sucralose

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

Description

Acetaminophen 160 mg

Purpose

Pain reliever/fever reducer


Medication Information

Purpose

Pain reliever/fever reducer

Description

Acetaminophen 160 mg

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.

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
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.

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?

1-855-423-2630

Principal Display Panel

EQUALINE ®

compare to

Children’s Tylenol® Chewables


active ingredient**

NDC 41163-045-08

children's

acetaminophen

160 mg, chewable tablets

pain reliever/fever reducer

for ages 2-11

bubble gum flavor

aspirin free

• ibuprofen free

CHEW OR CRUSH TABLETS COMPLETELY BEFORE SWALLOWING.

DO NOT SWALLOW TABLETS WHOLE.

24 chewable tablets

actual size

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER

UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

**This product is not manufactured or distributed by Kenvue Inc.,

owner of the registered trademark Children’s Tylenol® Chewables.

50844       REV0424D45008

100% Quality

GUARANTEED

Like it or let us make it right.

That's our quality promise.

855-423-2630

DISTRIBUTED BY UNFI

PROVIDENCE, RI 02903 USA

Equaline 44-450
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
  • any new symptoms appear 
  • redness or swelling is present
Keep Out of Reach of Children.

In case of overdose, get medical help or contact a Poison Control Center 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:
    • headache
    • sore throat
    • flu
    • toothache
    • 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
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.

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?)

1-855-423-2630

Principal Display Panel

EQUALINE ®

compare to

Children’s Tylenol® Chewables


active ingredient**

NDC 41163-045-08

children's

acetaminophen

160 mg, chewable tablets

pain reliever/fever reducer

for ages 2-11

bubble gum flavor

aspirin free

• ibuprofen free

CHEW OR CRUSH TABLETS COMPLETELY BEFORE SWALLOWING.

DO NOT SWALLOW TABLETS WHOLE.

24 chewable tablets

actual size

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER

UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

**This product is not manufactured or distributed by Kenvue Inc.,

owner of the registered trademark Children’s Tylenol® Chewables.

50844       REV0424D45008

100% Quality

GUARANTEED

Like it or let us make it right.

That's our quality promise.

855-423-2630

DISTRIBUTED BY UNFI

PROVIDENCE, RI 02903 USA

Equaline 44-450
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
  • any new symptoms appear 
  • redness or swelling is present
Keep Out of Reach of Children. (Keep out of reach of children.)

In case of overdose, get medical help or contact a Poison Control Center 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


Raw Label Data

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