Signature Select 44-045-30 Ml

Signature Select 44-045-30 Ml
SPL v8
SPL
SPL Set ID 743af02c-c762-42f5-8e01-2f62da15e04e
Route
ORAL
Published
Effective Date 2025-08-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (1000 mg)
Inactive Ingredients
Anhydrous Citric Acid Glycerin High Fructose Corn Syrup Polyethylene Glycol, Unspecified Propylene Glycol Water Sodium Benzoate Sodium Metabisulfite Saccharin Sodium Sucralose

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-07-15

Description

Acetaminophen 1,000 mg

Purpose

Pain reliever/fever reducer


Medication Information

Purpose

Pain reliever/fever reducer

Description

Acetaminophen 1,000 mg

Uses
  • temporarily relieves minor aches and pains due to:
    • muscular aches
    • toothache
    • backache
    • minor pain from arthritis
    • the common cold
    • premenstrual and menstrual cramps
    • headache
  • temporarily reduces fever
Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

  • more than 4,000 mg of acetaminophen in 24 hours
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

  • blisters
  • rash
  • skin reddening

If a skin reaction occurs, stop use and seek medical help right away.

Directions
  • do not take more than directed
  • mL = milliliter 
  • only use the dose cup provided
  • adults and children 12 years and over
    • take 30 mL every 6 hours while symptoms last
    • do not take more than 90 mL in 24 hours, unless directed by a doctor
    • do not take for more than 10 days unless directed by a doctor
  • children under 12 years: 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
  • each 30 mL contains: sodium 11 mg
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • use by expiration date on package

Inactive Ingredients

anhydrous citric acid, flavor, glycerin, high fructose corn syrup, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium metabisulfite, sodium saccharin, sucralose

Questions Or Comments?

1-800-426-9391

Principal Display Panel

Signature

SELECT™

NDC 21130-945-19

PAIN RELIEVER

EXTRA STRENGTH

ACETAMINOPHEN


1,000 mg per 30 mL

-Pain Reliever/Fever Reducer

CHERRY FLAVOR

• Dye Free • Contains no aspirin

Ages 12 Years

and Over

F-045-19 REVC

8 FL OZ (237 mL)

TAMPER EVIDENT: DO NOT USE IF PRINTED

NECK WRAP IS BROKEN OR MISSING

B-045-19

REV0123B

50844               REV0224C04519

DISTRIBUTED BY: BETTER LIVING BRANDS LLC

P.O. BOX 99, PLEASANTON, CA 94566-0009

‡1-888-723-3929

LOVE IT OR IT'S ON US‡

Signature Select 44-045

 

Stop Use and Ask A Doctor If
  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days
  • any new symptoms appear
  • redness or swelling is present
If Pregnant Or Breast Feeding,

ask a health professional before use.

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.

Active Ingredient (in Each 30 Ml)

Acetaminophen 1,000 mg

Ask A Doctor Before Use If You Have

liver disease.

Ask A Doctor Or Pharmacist Before Use If You Are

taking the blood thinning drug warfarin.


Structured Label Content

Uses
  • temporarily relieves minor aches and pains due to:
    • muscular aches
    • toothache
    • backache
    • minor pain from arthritis
    • the common cold
    • premenstrual and menstrual cramps
    • headache
  • temporarily reduces fever
Purpose

Pain reliever/fever reducer

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

  • more than 4,000 mg of acetaminophen in 24 hours
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

  • blisters
  • rash
  • skin reddening

If a skin reaction occurs, stop use and seek medical help right away.

Directions
  • do not take more than directed
  • mL = milliliter 
  • only use the dose cup provided
  • adults and children 12 years and over
    • take 30 mL every 6 hours while symptoms last
    • do not take more than 90 mL in 24 hours, unless directed by a doctor
    • do not take for more than 10 days unless directed by a doctor
  • children under 12 years: do not use
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)
  • each 30 mL contains: sodium 11 mg
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • use by expiration date on package

Inactive Ingredients (Inactive ingredients)

anhydrous citric acid, flavor, glycerin, high fructose corn syrup, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium metabisulfite, sodium saccharin, sucralose

Questions Or Comments? (Questions or comments?)

1-800-426-9391

Principal Display Panel (Principal display panel)

Signature

SELECT™

NDC 21130-945-19

PAIN RELIEVER

EXTRA STRENGTH

ACETAMINOPHEN


1,000 mg per 30 mL

-Pain Reliever/Fever Reducer

CHERRY FLAVOR

• Dye Free • Contains no aspirin

Ages 12 Years

and Over

F-045-19 REVC

8 FL OZ (237 mL)

TAMPER EVIDENT: DO NOT USE IF PRINTED

NECK WRAP IS BROKEN OR MISSING

B-045-19

REV0123B

50844               REV0224C04519

DISTRIBUTED BY: BETTER LIVING BRANDS LLC

P.O. BOX 99, PLEASANTON, CA 94566-0009

‡1-888-723-3929

LOVE IT OR IT'S ON US‡

Signature Select 44-045

 

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days
  • any new symptoms appear
  • redness or swelling is present
If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

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.

Active Ingredient (in Each 30 Ml) (Active ingredient (in each 30 mL))

Acetaminophen 1,000 mg

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

liver disease.

Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)

taking the blood thinning drug warfarin.


Advanced Ingredient Data


Raw Label Data

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