sleep-aid

sleep-aid
SPL v2
SPL
SPL Set ID b4e11a36-94dc-274d-e053-2a95a90ab894
Route
oral
Published
Effective Date 2020-11-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
bromotheophylline (50 mg)
Inactive Ingredients
water fd&c blue no. 1 polyethylene glycol 400 sorbitol propylene glycol glycerin gelatin, unspecified povidone k30 titanium dioxide

Identifiers & Packaging

Pill Appearance
Imprint: 795 Shape: oval Color: blue Size: 14 mm Score: 1
Marketing Status
unapproved drug other active Since 2020-11-24

Description

Pamabrom 50mg


Medication Information

Warnings and Precautions

Ask a doctor or pharmacist before use if you are taking any other medication.

Stop use and ask a doctor if symptoms last for more than ten consecutive days.

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 right away.

Active Ingredient

Pamabrom 50mg

Indications and Usage

For the relief of

temporary water wieght gain

bloating

swelling

full feling associated with the premenstrual and menstrual periods

Dosage and Administration

Read all package direction and warnings before use.

Use only as directed.

Adults: One(1) softgel capsule after breakfast with a full glass of water.

Dose may be repeated after 6 hours, not to exceed four (4) softgel capsules in 24 hours.

Start taking 5 or 6 days before onset of period and continue until desired relief is obtained or end of period.

Drink 6 to 8 glasses of water daily.

For use by normally healthy adults only

Persons under 18 years of age should use only as directed by a doctor.

Description

Pamabrom 50mg

Section 34088-5

In case of overdose, get medical help or contact a Poison Control Center right away.

Section 50565-1

Keep out of reach of children.

Section 51727-6

FD&C Blue#1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol and titanium dioxide

Section 51945-4

Section 55105-1

Diuretic

Section 60561-8

Contents sealed: Each clear translucent blue-colored, oval shaped Diuretic softgel capsule bears the identifying mark "795".

Contents packaged ina bottle with a safety seal under cap. Do not use if seal appears broken.


Structured Label Content

Warnings and Precautions (34071-1)

Ask a doctor or pharmacist before use if you are taking any other medication.

Stop use and ask a doctor if symptoms last for more than ten consecutive days.

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 right away.

Active Ingredient (55106-9)

Pamabrom 50mg

Indications and Usage (34067-9)

For the relief of

temporary water wieght gain

bloating

swelling

full feling associated with the premenstrual and menstrual periods

Dosage and Administration (34068-7)

Read all package direction and warnings before use.

Use only as directed.

Adults: One(1) softgel capsule after breakfast with a full glass of water.

Dose may be repeated after 6 hours, not to exceed four (4) softgel capsules in 24 hours.

Start taking 5 or 6 days before onset of period and continue until desired relief is obtained or end of period.

Drink 6 to 8 glasses of water daily.

For use by normally healthy adults only

Persons under 18 years of age should use only as directed by a doctor.

Section 34088-5 (34088-5)

In case of overdose, get medical help or contact a Poison Control Center right away.

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 51727-6 (51727-6)

FD&C Blue#1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol and titanium dioxide

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Diuretic

Section 60561-8 (60561-8)

Contents sealed: Each clear translucent blue-colored, oval shaped Diuretic softgel capsule bears the identifying mark "795".

Contents packaged ina bottle with a safety seal under cap. Do not use if seal appears broken.


Advanced Ingredient Data


Raw Label Data

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