family wellness 164.000/164aa rev 2 - ab

family wellness 164.000/164aa rev 2 - ab
SPL v10
SPL
SPL Set ID 0ac1896d-7ed9-44e5-bf07-147826237273
Route
oral
Published
Effective Date 2025-01-16
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 2019-02-18

Purpose

Saline laxative

Description

Magnesium citrate 1.745g


Medication Information

Warnings

for this product

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

Saline laxative

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

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

Description

Magnesium citrate 1.745g

Principal Display Panel

NDC 55319-164-38

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

FAMILY Wellness ™

DYE-FREE

MAGNESIUM CITRATE

SALINE LAXATIVE

CHERRY FLAVOR

10 FL OZ (295 mL)

Storage

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

Disclaimer

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

Adverse Reaction

NOT 100% SATISFIED?

Return within 30 days to any Family Dollar store for a refund (with receipt) or exchange.

DISTRIBUTED BY:

MIDWOOD BRANDS, LLC

500 VOLVO PARKWAY

CHESAPEAKE, VA 23320

MADE IN THE US WITH US AND FOREIGN COMPONENTS 

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.

If Pregnant Or Breast Feeding,

ask 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.

Active Ingredient (in Each Fl Oz)

Magnesium citrate 1.745g

Ask A Doctor before Use If You Have
  • kidney disease
  • a magnesium 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

Warnings

for this product

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

Saline laxative

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

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 55319-164-38

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

FAMILY Wellness ™

DYE-FREE

MAGNESIUM CITRATE

SALINE LAXATIVE

CHERRY FLAVOR

10 FL OZ (295 mL)

Storage

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

Disclaimer

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

Adverse Reaction

NOT 100% SATISFIED?

Return within 30 days to any Family Dollar store for a refund (with receipt) or exchange.

DISTRIBUTED BY:

MIDWOOD BRANDS, LLC

500 VOLVO PARKWAY

CHESAPEAKE, VA 23320

MADE IN THE US WITH US AND FOREIGN COMPONENTS 

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.

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

ask 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.

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 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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