live betr llc sleep aid drug facts

live betr llc sleep aid drug facts
SPL v4
SPL
SPL Set ID 8c2d5514-62c1-4e98-8412-20534365b934
Route
oral
Published
Effective Date 2022-07-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
diphenhydramine (25 mg)
Inactive Ingredients
carnauba wax crospovidone (120 .mu.m) dibasic calcium phosphate dihydrate fd&c blue no. 1 fd&c blue no. 2 hypromellose, unspecified magnesium stearate microcrystalline cellulose polyethylene glycol, unspecified polysorbate 80 stearic acid titanium dioxide

Identifiers & Packaging

Pill Appearance
Imprint: L431 Shape: oval Color: blue Size: 11 mm Score: 1
Marketing Status
otc monograph drug active Since 2021-01-25

Purpose

Nighttime sleep-aid

Description

Diphenhydramine HCl 25 mg


Medication Information

Purpose

Nighttime sleep-aid

Directions

adults and children 12 years and over

take 2 caplets at bedtime if needed, or as directed by a doctor

children under 12 years

do not use

Other Information
  • each caplet contains: calcium 15 mg
  • store at 20-25°C (68-77°F). Avoid high humidity. Protect from light.
  • do not use if blister unit is broken or torn
Inactive Ingredients

carnauba wax, crospovidone, dibasic calcium phosphate dihydrate, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch, stearic acid, titanium dioxide

Description

Diphenhydramine HCl 25 mg

Principal Display Panel

Get Betr, Give Back.

Betr

sleep aid

DIPHENHYDRAMINE HCl CAPLETS 25 mg

Actual Size

Nighttime Sleep Aid

- Relief Of Occasional Sleeplessness

48 CAPLETS

Use

for relief of occasional sleeplessness

Do Not Use
  • in children under 12 years of age
  • with any other product containing diphenhydramine, even one used on skin
Questions Or Comments?

1-800-719-9260

When Using This Product
  • avoid alcoholic drinks
  • drowsiness may occur
  • do not drive a motor vehicle or operate machinery
Stop Use and Ask A Doctor If
  • sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness.
If Pregnant Or Breast Feeding,

ask a health professional before use.

Keep Out of Reach of Children.

Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Active Ingredient (in Each Caplet)

Diphenhydramine HCl 25 mg

Ask A Doctor Before Use If You Have
  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • trouble urinating due to an enlarged prostate gland
Ask A Doctor Or Pharmacist Before Use If You Are

taking sedatives or tranquilizers


Structured Label Content

Purpose

Nighttime sleep-aid

Directions

adults and children 12 years and over

take 2 caplets at bedtime if needed, or as directed by a doctor

children under 12 years

do not use

Other Information (Other information)
  • each caplet contains: calcium 15 mg
  • store at 20-25°C (68-77°F). Avoid high humidity. Protect from light.
  • do not use if blister unit is broken or torn
Inactive Ingredients (Inactive ingredients)

carnauba wax, crospovidone, dibasic calcium phosphate dihydrate, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch, stearic acid, titanium dioxide

Principal Display Panel

Get Betr, Give Back.

Betr

sleep aid

DIPHENHYDRAMINE HCl CAPLETS 25 mg

Actual Size

Nighttime Sleep Aid

- Relief Of Occasional Sleeplessness

48 CAPLETS

Use

for relief of occasional sleeplessness

Do Not Use (Do not use)
  • in children under 12 years of age
  • with any other product containing diphenhydramine, even one used on skin
Questions Or Comments? (Questions or comments?)

1-800-719-9260

When Using This Product (When using this product)
  • avoid alcoholic drinks
  • drowsiness may occur
  • do not drive a motor vehicle or operate machinery
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness.
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.)

Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Active Ingredient (in Each Caplet) (Active ingredient (in each caplet))

Diphenhydramine HCl 25 mg

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • trouble urinating due to an enlarged prostate gland
Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)

taking sedatives or tranquilizers


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)