NDC 70677-0009 Allergy

NDC Product Code 70677-0009

NDC CODE: 70677-0009

Proprietary Name: Allergy What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Product Characteristics

Color(s):
PINK (C48328)
Shape: CAPSULE (C48336)
Size(s):
11 MM
Imprint(s):
EL
Score: 1

NDC Code Structure

NDC 70677-0009-1

Package Description: 100 CARTON in 1 BOTTLE > 1 TABLET in 1 CARTON

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

NDC Product Information

Allergy with NDC 70677-0009 is a product labeled by Mckesson. The generic name of Allergy is . The product's dosage form is and is administered via form.

Labeler Name: Mckesson

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • CARNAUBA WAX (UNII: R12CBM0EIZ)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
  • D&C RED NO. 27 (UNII: 2LRS185U6K)
  • DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)
  • HYPROMELLOSES (UNII: 3NXW29V3WO)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
  • POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)
  • POLYSORBATE 80 (UNII: 6OZP39ZG8H)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • POLYVINYL ALCOHOL (UNII: 532B59J990)
  • POVIDONE (UNII: FZ989GH94E)
  • STARCH, CORN (UNII: O8232NY3SJ)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • TALC (UNII: 7SEV7J4R1U)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Mckesson
Labeler Code: 70677
Start Marketing Date: 11-25-2016 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2019 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: I - INACTIVATED, the listing data was inactivated by the FDA. What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Information for Patients

Diphenhydramine

Diphenhydramine is pronounced as (dye fen hye' dra meen)

Why is diphenhydramine medication prescribed?
Diphenhydramine is used to relieve red, irritated, itchy, watery eyes; sneezing; and runny nose caused by hay fever, allergies, or the common cold. Diphenhydramine is als...
[Read More]

* Please review the disclaimer below.

Allergy Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Active Ingredient

(in each tablet) Diphenhydramine HCl 25 mg

Purpose

Antihistamine

Uses

  • Temporarily relieves these symptoms of hay fever or other upper respiratory allergies:runny noseitching of the nose or throatsneezingitchy, watery eyestemporarily relieves these symptoms due to the common cold:runny nosesneezing

Warnings

  • Do not useto make a child sleepywith any other product containing diphenhydramine, even one used on skinAsk a doctor before use if you havea breathing problem such as emphysema or chronic bronchitisglaucomatrouble urinating due to an enlarged prostate glandAsk a doctor or pharmacist before use if you are taking sedatives or tranquilizersWhen using this productyou may get very drowsyavoid alcoholic drinksalcohol, sedatives & tranquilizers may increase drowsinessbe careful when driving a motor vehicle or operating machineryexcitability may occur, especially in childrenIf pregnant or breast-feeding, ask a health professional before use.

Keep Out Of Reach Of Children.

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

Directions

  • Take every 4 to 6 hoursdo not take more than 6 tablets in 24 hoursAge (Yr) Dose (tablets)Adults and children 12 years of age and overTake 1 to 2 tabletsChildren 6 to under 12 years of ageTake 1 tabletChildren under 6 years of agedo not use

Other Information

  • Store at 25°C(77 °F) excusrsions permitted between 15°-30°C (59°-86°F)protect from light and moisturemetal content: each tablet contains: Calcium 23mg, Magnesium: 0.2 mg, sodium 0.5 mg

Inactive Ingredients

Carnauba Wax, Colloidal silion dioxide, croscarmellose sodium, D&C red #27 al lake, dibasic calcium phosphate dihydrate, hypromellose, Lecithin,  magnesium stearate, microcrystalline cellulose, polyethylene glycol, Polyvinyl Alcohol, polysorbate, Povidone, Purified water, starch, sodium benozoate, talc,Titanium Dioxide

* Please review the disclaimer below.