Equaline 164.000/164aa Rev 2-ab

SPL v15

SPL

SPL Set ID db1bc651-1a35-4f92-a917-c6a19f421594

Route

ORAL

Published

Effective Date 2025-03-27

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

Magnesium citrate 1.745g

Purpose

Saline laxative

Medication Information

Purpose

Saline laxative

Description

Magnesium citrate 1.745g

Uses

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

Section 44425-7

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

Disclaimer

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

Questions?

1-855-423-2630

Adverse Reaction

Like it or let us make it right.

That's our quality promise.

855-423-2630

Distributed by UNFI

Providence, RI 02908 USA

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 41163-769-38

EQUALINE ^®

magnesium citrate

saline laxative

oral solution

saccharin free
non-pasteurized

DYE FREE

cherry flavor

10 FL OZ (296 mL)

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

If Pregnant Or Breast Feeding

ask help professional before use.

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

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

Section 44425-7 (44425-7)

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

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

Disclaimer

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

Questions?

1-855-423-2630

Adverse Reaction (ADVERSE REACTION)

Like it or let us make it right.

That's our quality promise.

855-423-2630

Distributed by UNFI

Providence, RI 02908 USA

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 41163-769-38

EQUALINE ^®

magnesium citrate

saline laxative

oral solution

saccharin free
non-pasteurized

DYE FREE

cherry flavor

10 FL OZ (296 mL)

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

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

ask help professional before use.

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

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

[{"name": "BENZOIC ACID", "unii": "8SKN0B0MIM", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CITRIC ACID MONOHYDRATE", "unii": "2968PHW8QP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "EDETATE DISODIUM ANHYDROUS", "unii": "8NLQ36F6MM", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SUCRALOSE", "unii": "96K6UQ3ZD4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM CATION", "unii": "T6V3LHY838", "classCode": "ACTIB", "strengthNumerator": "1.745", "strengthDenominator": "29.6", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"Uses": "for relief of occasional constipation (irregularity). Generally produces bowel movement in 1/2 to 6 hours", "44425-7": "Store at temperatures betweem 46° and 86°F (8° and 30° C)", "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", "Disclaimer": "Non-USP: Non-Carbonated, Non-Pasteurized; Contains Preservatives", "Questions?": "1-855-423-2630", "ADVERSE REACTION": "Like it or let us make it right. That's our quality promise. 855-423-2630 Distributed by UNFI Providence, RI 02908 USA", "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 41163-769-38 EQUALINE ® magnesium citrate saline laxative oral solution saccharin free non-pasteurized DYE FREE cherry flavor 10 FL OZ (296 mL) DO NOT USE IF TAMPER EVIDENT TWIST-OFF CAP IS MISSING, BROKEN OR SEPARATED FROM NECKRING", "If pregnant or breast-feeding": "ask help professional before use.", "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", "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."}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:05:47.700209 · Updated: 2026-03-14T23:13:47.581346