Top Care 164.000/1664aa Rev 2-ab

Top Care 164.000/1664aa Rev 2-ab
SPL v14
SPL
SPL Set ID d3cc7cb6-098e-413c-b1ad-7ebf5fa35269
Route
ORAL
Published
Effective Date 2025-04-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Magnesium Cation (1.745 g)
Inactive Ingredients
Benzoic Acid Citric Acid Monohydrate 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 SEPERATED FROM NECKRING.

Purpose

Saline laxative


Medication Information

Purpose

Saline laxative

Description

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

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

Questions?

Call 1-888-423-0139

Adverse Reaction

Non-USP: Non-Carbonated, Non-Pasteurized; CONTAINS PRESERVATIVES.

DISTRIBUTED BY TOPCO ASSOC LLC

ELK GROVE VILLAGE, IL 60007

(C)TOPCO VIJA0123

QUESTIONS? 1-888-423-0139

[email protected] www.topcarebrand.com

FORMULA BLENDED IN USA

QUALITY GUARANTEED

This TopCare product is laboratory tested to guarantee its highest quality.

Your total satisfaction is guaranteed.

Other Information

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

Inactive Ingredients

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

Principal Display Panel

TopCare ®

Health

NDC 36800-164-38

Magnesium Citrate

SALINE LAXATIVE

ORAL SOLUTION

For Relief of Occasional Constipation

CHERRY FLAVOR

Scan here for more information or call 1-888-423-0139

10 FL OZ (296 mL)

Tamper Evident Statement

DO NOT USE IF TAMPER EVIDENT TWIST-OFF CAP IS MISSING, BROKEN OR SEPERATED 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

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

Questions?

Call 1-888-423-0139

Adverse Reaction (ADVERSE REACTION)

Non-USP: Non-Carbonated, Non-Pasteurized; CONTAINS PRESERVATIVES.

DISTRIBUTED BY TOPCO ASSOC LLC

ELK GROVE VILLAGE, IL 60007

(C)TOPCO VIJA0123

QUESTIONS? 1-888-423-0139

[email protected] www.topcarebrand.com

FORMULA BLENDED IN USA

QUALITY GUARANTEED

This TopCare product is laboratory tested to guarantee its highest quality.

Your total satisfaction is guaranteed.

Other Information (Other information)

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

Inactive Ingredients (Inactive ingredients)

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

Principal Display Panel (principal display panel)

TopCare ®

Health

NDC 36800-164-38

Magnesium Citrate

SALINE LAXATIVE

ORAL SOLUTION

For Relief of Occasional Constipation

CHERRY FLAVOR

Scan here for more information or call 1-888-423-0139

10 FL OZ (296 mL)

Tamper Evident Statement

DO NOT USE IF TAMPER EVIDENT TWIST-OFF CAP IS MISSING, BROKEN OR SEPERATED 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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