Sominex Max

Manufacturer: Medtech Products Inc.
Effective date: 2025-10-23
Label type: HUMAN OTC DRUG LABEL
Version: 4
Source: full-release
Hydrated at: 2026-06-01 01:40:42

Label at a glance#

ProductSominex Max

Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE

Label structure10 sections

Dosage and administration

adults and children 12 years and older : take 1 caplet at bedtime if needed, or as directed by your doctor

Contacts and useful links#

PhonePoison Help1-800-222-1222

PhoneLabel contact1-866-255-5202

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

(in each caplet)

Diphenhydramine HCl 50 mg

Purpose

OTC - PURPOSE SECTION

Nighttime sleep-aid

Use

INDICATIONS & USAGE SECTION

Helps to reduce difficultly falling asleep

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

in children under 12 years of age
with any other product containing diphenhydramine, even one used on skin
with other antihistamines

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

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

OTC - ASK DOCTOR/PHARMACIST SECTION

taking sedatives or tranquilizers

When using this product

OTC - WHEN USING SECTION

avoid alcoholic beverages
be careful when driving a motor vehicle or operating machinery
drowsiness will occur

Stop use and ask a doctor if

OTC - STOP USE SECTION

sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness.

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

adults and children 12 years and older: take 1 caplet at bedtime if needed, or as directed by your doctor

Other information

OTHER SAFETY INFORMATION

store at room temperature 20º- 25ºC (68º-77ºF)
keep carton for future reference

Inactive ingredients

INACTIVE INGREDIENT SECTION

croscarmellose sodium, dicalcium phosphate, FD&C blue no. 1 lake, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, mineral oil, silica, stearate acid, talc, titanium dioxide, triacetin

Questions?

OTC - QUESTIONS SECTION

1-866-255-5202

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MAXIMUM STRENGTH FORMULA
Sominex^®
NIGHTTIME SLEEP-AID DIPHENHYDRAMINE HCl
16 TABLETS

A label of a medicine bottle AI-generated content may be incorrect.

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1085945	diphenhydrAMINE HCl 50 MG Oral Tablet	PSN	4
1086857	Sominex Maximum Strength 50 MG Oral Tablet	PSN	4
1086857	diphenhydramine hydrochloride 50 MG Oral Tablet [Sominex]	SBD	4
1085945	diphenhydramine hydrochloride 50 MG Oral Tablet	SCD	4
1086857	Sominex 50 MG Oral Tablet	SY	4
1086857	Sominex Maximum Strength 50 MG Oral Tablet	SY	4

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
DIPHENHYDRAMINE Pharmacologic Class Indexing	3	Indexing - Pharmacologic Class	20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
0e2e0f88-b076-afe1-4bdd-32bca4375bec	Product name	3	20250127
3e48c9c4-918d-5d23-2f0b-d2398b06be54	Product name	1	20140508
865c72dd-0d94-daac-f728-ddd4ded2a79e	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
63029-505-01	Sominex Max	1 in 1 BOX	TABLET	1	4
63029-505-07	Sominex Max	16 in 1 BLISTER PACK	TABLET	16	4
63029-505-16	Sominex Max	16 in 1 BLISTER PACK	TABLET	16	4
63029-505-16	Sominex Max	1 in 1 BOX	TABLET	1	4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63029-505-07	EA - Each	63029-505	991e5213-f034-46ba-b13e-02f49a654d62	1	2022-06-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
DIPHENHYDRAMINE HYDROCHLORIDE	ACTIVE INGREDIENT	TC2D6JAD40	1
DIPHENHYDRAMINE	ACTIVE MOIETY	8GTS82S83M	1
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	1
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE	INACTIVE INGREDIENT	O7TSZ97GEP	1
CARNAUBA WAX	INACTIVE INGREDIENT	R12CBM0EIZ	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	1
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	1
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 17 matching rows.

Sominex Max
Diphenhydramine HCl
DIPHENHYDRAMINE HYDROCHLORIDE
DIPHENHYDRAMINE
CROSCARMELLOSE SODIUM
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE
FD&C BLUE NO. 1
HYPROMELLOSE, UNSPECIFIED
LACTOSE, UNSPECIFIED FORM
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
MINERAL OIL
SILICON DIOXIDE
STEARIC ACID
TALC
TITANIUM DIOXIDE
TRIACETIN

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
63029-505	63029-505-07, 63029-505-01, 63029-505-16

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
DIPHENHYDRAMINE HYDROCHLORIDE	TC2D6JAD40	ACTIB
CROSCARMELLOSE SODIUM	M28OL1HH48	IACT
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE	O7TSZ97GEP	IACT
FD&C BLUE NO. 1	H3R47K3TBD	IACT
HYPROMELLOSE, UNSPECIFIED	3NXW29V3WO	IACT
LACTOSE, UNSPECIFIED FORM	J2B2A4N98G	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
CELLULOSE, MICROCRYSTALLINE	OP1R32D61U	IACT
MINERAL OIL	T5L8T28FGP	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
STEARIC ACID	4ELV7Z65AP	IACT
TALC	7SEV7J4R1U	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
TRIACETIN	XHX3C3X673	IACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
Version	Effective date	Source	Hydrated
3	2024-10-25	full-release	2026-06-01 00:32:22

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 44 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
CARNAUBA WAX	CARNAUBA WAX	R12CBM0EIZ	TABLET / ORAL	167.8 mg		Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET / ORAL		232 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
CARNAUBA WAX	CARNAUBA WAX	R12CBM0EIZ	TABLET / ORAL	167.8 mg		Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	TABLET / ORAL	27.53 mg		Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE	DIBASIC CALCIUM PHOSPHATE DIHYDRATE	O7TSZ97GEP	TABLET / ORAL		2442 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	TABLET / ORAL		1116 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET / ORAL		232 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	TABLET / ORAL		1116 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	TABLET / ORAL		1116 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET / ORAL		6184 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET / ORAL		980 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE	DIBASIC CALCIUM PHOSPHATE DIHYDRATE	O7TSZ97GEP	TABLET / ORAL		2442 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	TABLET / ORAL		1116 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET / ORAL		750 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET / ORAL		6184 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	TABLET / ORAL	27.53 mg		Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	TABLET / ORAL		1127 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	TABLET / ORAL		233 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
CARNAUBA WAX	CARNAUBA WAX	R12CBM0EIZ	TABLET / ORAL	167.8 mg		Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	TABLET / ORAL		233 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	TABLET / ORAL	27.53 mg		Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE	DIBASIC CALCIUM PHOSPHATE DIHYDRATE	O7TSZ97GEP	TABLET / ORAL		2442 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET / ORAL		750 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET / ORAL		6184 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET / ORAL		980 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
ALUMINUM OXIDE	ALUMINUM OXIDE	LMI26O6933	TABLET / ORAL	NA		Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	TABLET / ORAL	27.53 mg		Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	TABLET / ORAL		1127 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET / ORAL		980 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
ALUMINUM OXIDE	ALUMINUM OXIDE	LMI26O6933	TABLET / ORAL	NA		Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	TABLET / ORAL		1127 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET / ORAL		232 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
CARNAUBA WAX	CARNAUBA WAX	R12CBM0EIZ	TABLET / ORAL	167.8 mg		Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET / ORAL		980 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
ALUMINUM OXIDE	ALUMINUM OXIDE	LMI26O6933	TABLET / ORAL	NA		Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	TABLET / ORAL		233 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET / ORAL		6184 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET / ORAL		750 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
ALUMINUM OXIDE	ALUMINUM OXIDE	LMI26O6933	TABLET / ORAL	NA		Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET / ORAL		750 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	TABLET / ORAL		1127 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET / ORAL		232 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE	DIBASIC CALCIUM PHOSPHATE DIHYDRATE	O7TSZ97GEP	TABLET / ORAL		2442 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	TABLET / ORAL		233 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sominex Max	DIPHENHYDRAMINE HCL	Medtech Products Inc.	e8f6991f-c47a-4d12-934b-04fdf092dac3	2025-10-23	Warnings	Exact identifier ndc (package): 63029-505-16 ndc (package): 63029-505-07 ndc (package): 63029-505-01 ndc (product): 63029-505 ndc11 (package): 63029050501 ndc11 (package): 63029050516 ndc11 (package): 63029050507 spl id: dc571463-dbec-4984-ad42-51732470104e spl set id: e8f6991f-c47a-4d12-934b-04fdf092dac3

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.