Sominex Max Tablet
FDA Label NDC 63029-505

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Medtech Products Inc. for the product Sominex Max (NDC 63029-505). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient, purpose, use, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

(in each caplet)

Diphenhydramine HCl 50mg

Purpose

Nighttime sleep-aid

Use

helps reduce difficultly falling asleep

Do Not Use

  • 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

  • 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 beverages

  • be careful when driving a motor vehicle or operating 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 accidental overdose get medical help or contact a Poison Control Center right away.

Directions

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

Other Information

  • each caplet contains: calcium 50 mg
  • store below 25°C (77°F)

Inactive Ingredients

carnauba wax, crospovidone, dibasic calcium phosphate, FD&C blue #1 aluminum lake, hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, silicon dioxide, starch, titanium dioxide

Questions?

1-866-255-5202 (English/Spanish)









Principal Display Panel

MAXIMUM FORMULA
Sominex
NIGHTTIME SLEEP-AID DIPHENHYDRAMINE HCl
16 TABLETS

Principal Display Panelmaximum Formulasominexnighttime Sleep-aid Diphenhydramine HCl16 Tablets (Sominex Max 01)

Principal Display Panelmaximum Formulasominexnighttime Sleep-aid Diphenhydramine HCl16 Tablets (Sominex Max 01)

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