GOOD REMEDIES NIGHTTIME SLEEP AID CAPLETS- diphenhydramine hydrochloride tablet

GOOD REMEDIES Nighttime Sleep Aid Caplets by

Drug Labeling and Warnings

GOOD REMEDIES Nighttime Sleep Aid Caplets by is a Otc medication manufactured, distributed, or labeled by Strive Pharmaceuticals Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient (in each caplet)

Diphenhydramine HCl 25 mg

Purpose

Nighttime sleep aid

Use

for relief of occasional sleeplessness

Warnings

Do not use
in children under 12 years of age
with any other product containing diphenhydramine, even one used on skin

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

When using this product
avoid alcoholic drinks
drowsiness will 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. Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.

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 22 mg
store at room temperature between 20°-25°C (68°-77°F)
protect from light, heat and moisture

Inactive ingredients

croscarmellose sodium, dicalcium phosphate, FD&C blue no. 1, FD&C blue no. 2, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, talc, titanium dioxide

Questions or comments?

1-888-577-8033 Monday - Friday 8am - 4pm EST

SPL UNCLASSIFIED SECTION

Compare to the active ingredient of TYLENOL PM® Simply Sleep®*

Helps you fall asleep
Safe, non-habit forming

READ AND KEEP OUTER CARTON FOR COMPLETE PRODUCT WARNINGS AND INFORMATION

*This product is not manufactured or distributed by Kenvue, Inc., owner of the registered trademarks Tylenol PM® and Simply Sleep®.

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Distributed by: Strive Pharmaceuticals Inc.,
East Brunswick, NJ 08816
PRODUCT OF INDIA

Packaging

INGREDIENTS AND APPEARANCE

GOOD REMEDIES NIGHTTIME SLEEP AID CAPLETS 
diphenhydramine hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70692-011
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	25 mg

Inactive Ingredients
Ingredient Name	Strength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	blue	Score	no score
Shape	OVAL	Size	11mm
Flavor		Imprint Code	DB
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70692-011-06	1 in 1 CARTON	10/28/2024
1		60 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M010	10/28/2024

Labeler - Strive Pharmaceuticals Inc. (080028013)