Fred's Saline Enema Twin Pack

Fred's Saline Enema Twin Pack
SPL v1
SPL
SPL Set ID 7d15057f-eb3b-477f-ab14-68c3c38ea910
Route
RECTAL
Published
Effective Date 2018-12-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Phosphate Ion (7 g) Sodium Cation (19 g)
Inactive Ingredients
Benzalkonium Chloride Edetate Disodium Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2019-12-20

Description

Drug Facts


Medication Information

Description

Drug Facts

Use
  • relieves occasional constipation
  • this product generally produces a bowel movement in 1 to 5 minutes
Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away: 800-222-1222.

Section 50568-5

Ask a doctor or pharmacist before use if you are taking any other drug. Take this product two or more hours before or after other drugs. Laxatives may affect how other drugs work.

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1
Active ingredients (in each 118mL delivered dose) Purpose
Dibasic Sodium Phosphate 7 g Saline laxative
Monobasic Sodium Phosphate 19 g Saline laxative
Warnings

For rectal use only.

Dosage Warning

Using more than one enema in 24 hours can be harmful.

Other Information
  • each 118 ml contains 4.3 g sodium
  • store at 15 to 30°C (59 to 86°F)
  • additional liquids by mouth are recommended while using this product
  • Tamper Evident: DO NOT USE IF TOP OR BOTTOM FLAP OF CARTON IS TORN OR MISSING
Inactive Ingredients

benzalkonium chloride, disodium EDTA, purified water

Questions Or Comments?

866-323-0107 or www.natureplex.com

When Using This Product
  • do not use more than directed. Serious side effects may occur from excess dosage
  • do not use for more than 3 days without asking a doctor
Stop Use and Ask A Doctor If
  • you have rectal bleeding
  • you have no bowel movement within 30 minutes of enema use
  • you have symptoms of dehydration (thirstiness, dizziness, vomiting, urinating less often than normal)

These symptoms may indicate a serious condition.

Ask A Doctor Before Use If You
  • already used a laxative for more than 3 days
  • have kidney disease, have heart problems, or are dehydrated
  • are 55 years old or older
  • are on a sodium-restricted diet
  • have abdominal pain, nausea, or vomiting
  • have a sudden change in bowel habits lasing more than 2 weeks
Directions (or As Directed By A Doctor)

Single daily dosage (per 24 hours)

Do not use if taking another sodium phosphate product.

Do not use more unless directed by a doctor. See Warnings.

Adults and children 12 years old and older 1 bottle once daily
Children 2 to under 12 years old Use Pediatric Enema
Children under 2 years DO NOT USE
Principal Display Panel 133 Ml Bottle Carton

NDC 55315-301-01

fred's

Pharmacy

SALINE

enema

TWIN PACK

For Relief of

Occasional

Constipation

Ready-to-Use

Soft, Easy to use Bottle

Not Made with Natural

Rubber Latex

2

BOTTLES

4.5 FL OZ (133 mL) each

Compare To

Fleet®*


Structured Label Content

Use
  • relieves occasional constipation
  • this product generally produces a bowel movement in 1 to 5 minutes
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away: 800-222-1222.

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are taking any other drug. Take this product two or more hours before or after other drugs. Laxatives may affect how other drugs work.

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1 (55105-1)
Active ingredients (in each 118mL delivered dose) Purpose
Dibasic Sodium Phosphate 7 g Saline laxative
Monobasic Sodium Phosphate 19 g Saline laxative
Warnings

For rectal use only.

Dosage Warning (Dosage warning)

Using more than one enema in 24 hours can be harmful.

Other Information (Other information)
  • each 118 ml contains 4.3 g sodium
  • store at 15 to 30°C (59 to 86°F)
  • additional liquids by mouth are recommended while using this product
  • Tamper Evident: DO NOT USE IF TOP OR BOTTOM FLAP OF CARTON IS TORN OR MISSING
Inactive Ingredients (Inactive ingredients)

benzalkonium chloride, disodium EDTA, purified water

Questions Or Comments? (Questions or comments?)

866-323-0107 or www.natureplex.com

When Using This Product (When using this product)
  • do not use more than directed. Serious side effects may occur from excess dosage
  • do not use for more than 3 days without asking a doctor
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • you have rectal bleeding
  • you have no bowel movement within 30 minutes of enema use
  • you have symptoms of dehydration (thirstiness, dizziness, vomiting, urinating less often than normal)

These symptoms may indicate a serious condition.

Ask A Doctor Before Use If You (Ask a doctor before use if you)
  • already used a laxative for more than 3 days
  • have kidney disease, have heart problems, or are dehydrated
  • are 55 years old or older
  • are on a sodium-restricted diet
  • have abdominal pain, nausea, or vomiting
  • have a sudden change in bowel habits lasing more than 2 weeks
Directions (or As Directed By A Doctor) (Directions (or as directed by a doctor))

Single daily dosage (per 24 hours)

Do not use if taking another sodium phosphate product.

Do not use more unless directed by a doctor. See Warnings.

Adults and children 12 years old and older 1 bottle once daily
Children 2 to under 12 years old Use Pediatric Enema
Children under 2 years DO NOT USE
Principal Display Panel 133 Ml Bottle Carton (PRINCIPAL DISPLAY PANEL - 133 mL Bottle Carton)

NDC 55315-301-01

fred's

Pharmacy

SALINE

enema

TWIN PACK

For Relief of

Occasional

Constipation

Ready-to-Use

Soft, Easy to use Bottle

Not Made with Natural

Rubber Latex

2

BOTTLES

4.5 FL OZ (133 mL) each

Compare To

Fleet®*


Advanced Ingredient Data


Raw Label Data

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