RELIEF EPSOM SALT- magnesium sulfate heptahydrate granule 
BLUE CROSS LABORATORIES, INC.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Relief Epsom Salts

Active Ingredients  Purpose

Magnesium Sulfate [heptahydrate]100%          Saline Laxative

-For relief of occasional constipation (irregularity)

-this product generally produces bowel movement in 1/2 to 6 hours

Keep out of reach of children

-For relief of occasional constipation (irregularity)

-this product generally produces bowel movement in 1/2 to 6 hours

Warnings

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 of 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.

If pregnant or breast-feeding, as a 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.

Directions

-do not exceed more than 2 doses per day

-drink a full glass (8 ounces) of liquid with each dose

-dissolve the dose in 8 ounces of water. Lemon juice may be added to improve the taste.

-adults and children 12 years and over: 2 to 4 level teaspoons (10 to 20 grams) daily

-children 6 to under 12 years: 1 to 2 level teaspoons (5 to 10 grams) daily

-children under 6 years: consult a doctor

Other information

Magnesium content: 495 mg per teaspoon

Relief

Epsom Salt

Magnesium Sulfate

NET WT  8 LB (3.63kg)

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RELIEF EPSOM SALT 
magnesium sulfate heptahydrate granule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:22431-248
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MAGNESIUM SULFATE HEPTAHYDRATE (UNII: SK47B8698T) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM SULFATE HEPTAHYDRATE3.63 kg  in 3.63 kg
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:22431-248-013.63 kg in 1 BAG; Type 0: Not a Combination Product08/22/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33408/22/2017
Labeler - BLUE CROSS LABORATORIES, INC. (008298879)
Registrant - BLUE CROSS LABORATORIES, INC. (008298879)
Establishment
NameAddressID/FEIBusiness Operations
Hefei Yatai Daily Chemical Products Co., Ltd.654641724manufacture(22431-248)

Revised: 12/2019
Document Id: 5b81c31e-58d9-4a4d-8dd6-0cedb94eca1b
Set id: c16b34ab-fdc8-4f71-b3f1-feff0493210b
Version: 3
Effective Time: 20191224
 
BLUE CROSS LABORATORIES, INC.