Sohmed™ Allergy

Sohmed™ Allergy
SPL v1
SPL
SPL Set ID 1e650657-83e5-4704-863b-c420390a2247
Route
ORAL
Published
Effective Date 2013-08-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (25 mg)
Inactive Ingredients
Croscarmellose Sodium D&c Red No. 27 Hypromelloses Lactose Magnesium Stearate Cellulose, Microcrystalline Polyethylene Glycol 6000 Silicon Dioxide Titanium Dioxide Polysorbate 20

Identifiers & Packaging

Pill Appearance
Imprint: CRX Shape: oval Color: red Size: 11 mm Score: 2
Marketing Status
OTC MONOGRAPH FINAL Active Since 2013-08-25

Description

Drug Facts

Purpose

Antihistamine


Medication Information

Purpose

Antihistamine

Description

Drug Facts

Uses
  • temporarily relieves symptoms due to hay fever or other upper respiratory allergies :
    • runny nose
    • sneezing
    • itchy, watery eyes
    • itching of the nose or throat
  • temporarily relieves symptoms due to the common cold:
    • runny nose
    • sneezing
Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.

Section 50568-5

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers

Section 50570-1

Do not use with any other product containing diphenhydramine, even one used on skin.

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Directions
  • take every 4 to 6 hours
  • do not take more than 6 times in 24 hours
adults and children 12 years and over 1 to 2 caplets
children 6 to under 12 years 1 caplet
children under 6 years consult a doctor
Overdose Warning

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

Other Information
  • Store between 20°-25°C (68°-77°F).

    Avoid high humidity. Protect from light
  • See end flap for expiration date and lot number
Inactive Ingredients

croscarmellose sodium, D&C Red #27, hydroxypropylmethyl cellulose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, silicon dioxide, titanium dioxide, May contain polysorbate.

Question Or Comments?

1 (856) 2863646

When Using This Product
  • marked drowsiness may occur
  • avoid alcoholic drinks
  • alcohol, sedatives and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery
  • excitability may occur, especially in children
Active Ingredients (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
Principal Display Panel 24 Caplet Bottle Carton

NDC XXXXXXXXXX

SohMed™

*Compare to the active ingredients in Benadryl® Allergy Ultratab®

Antihistamine

Allergy

Diphenhydramine HCl 25 mg

24 Caplets

• Runny Nose • Itchy, Watery Eyes

• Sneezing • Itchy throat


Structured Label Content

Uses
  • temporarily relieves symptoms due to hay fever or other upper respiratory allergies :
    • runny nose
    • sneezing
    • itchy, watery eyes
    • itching of the nose or throat
  • temporarily relieves symptoms due to the common cold:
    • runny nose
    • sneezing
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers

Section 50570-1 (50570-1)

Do not use with any other product containing diphenhydramine, even one used on skin.

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Purpose

Antihistamine

Directions
  • take every 4 to 6 hours
  • do not take more than 6 times in 24 hours
adults and children 12 years and over 1 to 2 caplets
children 6 to under 12 years 1 caplet
children under 6 years consult a doctor
Overdose Warning (Overdose warning)

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

Other Information (Other information)
  • Store between 20°-25°C (68°-77°F).

    Avoid high humidity. Protect from light
  • See end flap for expiration date and lot number
Inactive Ingredients (Inactive ingredients)

croscarmellose sodium, D&C Red #27, hydroxypropylmethyl cellulose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, silicon dioxide, titanium dioxide, May contain polysorbate.

Question Or Comments? (Question or comments?)

1 (856) 2863646

When Using This Product (When using this product)
  • marked drowsiness may occur
  • avoid alcoholic drinks
  • alcohol, sedatives and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery
  • excitability may occur, especially in children
Active Ingredients (in Each Caplet) (Active ingredients (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
Principal Display Panel 24 Caplet Bottle Carton (PRINCIPAL DISPLAY PANEL - 24 Caplet Bottle Carton)

NDC XXXXXXXXXX

SohMed™

*Compare to the active ingredients in Benadryl® Allergy Ultratab®

Antihistamine

Allergy

Diphenhydramine HCl 25 mg

24 Caplets

• Runny Nose • Itchy, Watery Eyes

• Sneezing • Itchy throat


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)