Signature Care 166.000/166aa Rev 1-ab

Signature Care 166.000/166aa Rev 1-ab
SPL v13
SPL
SPL Set ID 07732845-c9ce-47bb-8b63-36a3d5ddf8b7
Route
ORAL
Published
Effective Date 2025-04-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Magnesium Cation (1.745 g)
Inactive Ingredients
Citric Acid Monohydrate Benzoic Acid Edetate Disodium Anhydrous Sucralose Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2018-02-18

Description

DO NOT USE IF TAMPER EVIDENT TWIST-OFF CAP IS MISSING, BROKEN OR SEPARATED FROM NECKRING

Purpose

Saline laxative


Medication Information

Purpose

Saline laxative

Description

DO NOT USE IF TAMPER EVIDENT TWIST-OFF CAP IS MISSING, BROKEN OR SEPARATED FROM NECKRING

Uses
  • for relief of occasional constipation (irregularity).
  • Generally produces bowel movement in 1/2 to 6 hours
Storage

Store at temperatures betweem 46° and 86°F (8° and 30° C)

Warnings

for this product

Directions
  • shake well before using
  • drink a full glass (8 ounces) of liquid with each dose
  • may be taken as a single daily dose or in divided doses

adults and children 12 years of age and over - 6.5 to 10 fl oz maximum 10 fl oz in 24 hours

children 6 to under 12 years of age - 3 to 7 fl oz maximum 7 fl oz in 24 hours

children 2 to under 6 years of age - 2 to 3 fl oz maximum 3 fl oz in 24 hours

children under 2 years of age - ask a doctor

Adverse Reaction

DISTRIBUTED BY BETTER LIVING BRANDS LLC

P.O. BOX 99

PLEASANTON, CA

94566-0009

1-888-723-3929

Non-USP: Non-Carbonated, Non-Pasteurized; Contains Preservatives

Scan here for more information

how2recycle.info

Empty & Replace Cap

PLASTIC BOTTLE

Other Information
  • each fl oz contains: magnesium 290 mg
  • each fl oz contains: sodium 1 mg
Inactive Ingredients

benzoic acid, citric acid, disodium EDTA, flavor, sucralose, water

Principal Display Panel

NDC 21130-709-38

Signature Care ®

Quality Guaranteed

Oral Solution

Magnesium Citrate

SALINE LAXATIVE

SACCHARIN FREE

LEMON FLAVOR

10 FL OZ (296 mL)

Tamper Evident Statement

DO NOT USE IF TAMPER EVIDENT TWIST-OFF CAP IS MISSING, BROKEN OR SEPARATED FROM NECKRING

Stop Use and Ask A Doctor If

you have rectal bleeding or failure to have a bowel movement after use. These could be signs of a serious condition.

Keep Out of Reach of Children.

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

If Pregnant Or Breast Feeding,

ask help professional before use.

Active Ingredient (in Each Fl Oz)

Magnesium citrate 1.745g

Ask A Doctor before Use If You Have
  • kidney disease
  • a magnesium or sodium restricted diet
  • abdominal pain, nausea, or vomiting
  • noticed a sudden change in bowel habits that persists over a period of 2 weeks
  • already used a laxative for a period longer than 1 week
Ask A Doctor Or Pharmacist before Use If You Are
  • taking any other drug.
  • Take this product 2 or more hours before or after other drugs. Laxatives may affect how other drugs work.

Structured Label Content

Uses
  • for relief of occasional constipation (irregularity).
  • Generally produces bowel movement in 1/2 to 6 hours
Purpose

Saline laxative

Storage

Store at temperatures betweem 46° and 86°F (8° and 30° C)

Warnings

for this product

Directions
  • shake well before using
  • drink a full glass (8 ounces) of liquid with each dose
  • may be taken as a single daily dose or in divided doses

adults and children 12 years of age and over - 6.5 to 10 fl oz maximum 10 fl oz in 24 hours

children 6 to under 12 years of age - 3 to 7 fl oz maximum 7 fl oz in 24 hours

children 2 to under 6 years of age - 2 to 3 fl oz maximum 3 fl oz in 24 hours

children under 2 years of age - ask a doctor

Adverse Reaction (ADVERSE REACTION)

DISTRIBUTED BY BETTER LIVING BRANDS LLC

P.O. BOX 99

PLEASANTON, CA

94566-0009

1-888-723-3929

Non-USP: Non-Carbonated, Non-Pasteurized; Contains Preservatives

Scan here for more information

how2recycle.info

Empty & Replace Cap

PLASTIC BOTTLE

Other Information (other information)
  • each fl oz contains: magnesium 290 mg
  • each fl oz contains: sodium 1 mg
Inactive Ingredients (Inactive ingredients)

benzoic acid, citric acid, disodium EDTA, flavor, sucralose, water

Principal Display Panel (principal display panel)

NDC 21130-709-38

Signature Care ®

Quality Guaranteed

Oral Solution

Magnesium Citrate

SALINE LAXATIVE

SACCHARIN FREE

LEMON FLAVOR

10 FL OZ (296 mL)

Tamper Evident Statement

DO NOT USE IF TAMPER EVIDENT TWIST-OFF CAP IS MISSING, BROKEN OR SEPARATED FROM NECKRING

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

you have rectal bleeding or failure to have a bowel movement after use. These could be signs of a serious condition.

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.

If Pregnant Or Breast Feeding, (if pregnant or breast-feeding,)

ask help professional before use.

Active Ingredient (in Each Fl Oz) (Active ingredient (in each fl oz))

Magnesium citrate 1.745g

Ask A Doctor before Use If You Have (Ask a doctor before use if you have)
  • kidney disease
  • a magnesium or sodium restricted diet
  • abdominal pain, nausea, or vomiting
  • noticed a sudden change in bowel habits that persists over a period of 2 weeks
  • already used a laxative for a period longer than 1 week
Ask A Doctor Or Pharmacist before Use If You Are (Ask a doctor or pharmacist before use if you are)
  • taking any other drug.
  • Take this product 2 or more hours before or after other drugs. Laxatives may affect how other drugs work.

Advanced Ingredient Data


Raw Label Data

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