Onelax (magnesium Citrate)

Onelax (magnesium Citrate)
SPL v1
SPL
SPL Set ID d56ec7c8-551c-46ce-8524-22f2729e92a1
Route
ORAL
Published
Effective Date 2023-02-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Magnesium Cation (1.745 g)
Inactive Ingredients
Water Anhydrous Citric Acid Sodium Benzoate Saccharin Sodium Sorbic Acid Edetate Disodium

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2023-01-02

Description

Magnesium citrate 1.745g

Purpose

Saline laxative


Medication Information

Purpose

Saline laxative

Description

Magnesium citrate 1.745g

Uses
  • relieves occasional constipation (irregularity)
  • generally produces bowel movement in 1/2 to 6 hours
Section 51945-4

Directions
  • 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  1/2 bottle to 1 bottle (10 fl oz)
 children 6 to 11 years of age  1/3 bottle to 1/2 bottle
 children under 6 years of age  consult a doctor

Do Not Use

 laxative products for longer than 1 week unless directed by a doctor.

Other Information
  • each fliud ounce contains: magnesium 280 mg, sodium 6.7 mg
  • store between 46º-86ºF (8º-30ºC). Do not refrigerate.
  • protect from excessive heat and freezing
  • discard unused product within 24 hours of opening bottle
Inactive Ingredients

Purified water, citric acid, lemon flavor, sodium benzoate, saccharin sodium, sorbic acid, disodium edetate

Questions Or Comments?

Call  toll-free 1-877-225-6999

Manufactured for:

Akron Pharma Inc.,

Fairfield, NJ-07004 

www.akronpharma.com

When Using This Product

do not exceed the maximum recommended daily dosage in a 24 hour period.

Stop Use and Ask A Doctor If

you have rectal bleeding or no bowel movement after use. These could be signs of a serious condition.

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 (1-800-222-1222) right away.

Ask A Doctor Before Use If You Have
  • kidney disease
  • a magnesium restricted diet
  • a sodium restricted diet
  • stomach pain, nausea or vomiting
  • noticed a sudden change in bowel habits that lasts more than 1 week
Active Ingredient (30ml (approx. 1 Fl. Oz))

Magnesium citrate 1.745g

Ask A Doctor Or Pharmacist Before Use If You

are presently taking a prescription drug.


Structured Label Content

Uses
  • relieves occasional constipation (irregularity)
  • generally produces bowel movement in 1/2 to 6 hours
Section 51945-4 (51945-4)

Purpose

Saline laxative

Directions
  • 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  1/2 bottle to 1 bottle (10 fl oz)
 children 6 to 11 years of age  1/3 bottle to 1/2 bottle
 children under 6 years of age  consult a doctor

Do Not Use (Do not use)

 laxative products for longer than 1 week unless directed by a doctor.

Other Information (Other information)
  • each fliud ounce contains: magnesium 280 mg, sodium 6.7 mg
  • store between 46º-86ºF (8º-30ºC). Do not refrigerate.
  • protect from excessive heat and freezing
  • discard unused product within 24 hours of opening bottle
Inactive Ingredients (Inactive ingredients)

Purified water, citric acid, lemon flavor, sodium benzoate, saccharin sodium, sorbic acid, disodium edetate

Questions Or Comments? (Questions or comments?)

Call  toll-free 1-877-225-6999

Manufactured for:

Akron Pharma Inc.,

Fairfield, NJ-07004 

www.akronpharma.com

When Using This Product (When using this product)

do not exceed the maximum recommended daily dosage in a 24 hour period.

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

you have rectal bleeding or no bowel movement after use. These could be signs of a serious condition.

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 (1-800-222-1222) right away.

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • kidney disease
  • a magnesium restricted diet
  • a sodium restricted diet
  • stomach pain, nausea or vomiting
  • noticed a sudden change in bowel habits that lasts more than 1 week
Active Ingredient (30ml (approx. 1 Fl. Oz)) (Active ingredient (30ml (approx. 1 Fl. oz)))

Magnesium citrate 1.745g

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

are presently taking a prescription drug.


Advanced Ingredient Data


Raw Label Data

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