NDC 33261-798 Acetadryl

NDC Product Code 33261-798

NDC CODE: 33261-798

Proprietary Name: Acetadryl 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.

Product Characteristics

Color(s):
BLUE (C48333)
Shape: OVAL (C48345)
Size(s):
18 MM
Imprint(s):
GP325
Score: 1

NDC Code Structure

  • 33261 - Aidarex Pharmaceuticals Llc

NDC 33261-798-50

Package Description: 50 TABLET, FILM COATED in 1 BOTTLE, PLASTIC

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

NDC Product Information

Acetadryl with NDC 33261-798 is a product labeled by Aidarex Pharmaceuticals Llc. The product's dosage form is and is administered via form. The RxNorm Crosswalk for this NDC code indicates multiple RxCUI concepts are associated to this product: 1092189 and 1116532.

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.

  • CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
  • CROSPOVIDONE (UNII: 68401960MK)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • HYDROXYPROPYL CELLULOSE (TYPE H) (UNII: RFW2ET671P)
  • HYPROMELLOSE 2208 (100 MPA.S) (UNII: B1QE5P712K)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
  • POVIDONES (UNII: FZ989GH94E)
  • STARCH, CORN (UNII: O8232NY3SJ)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

Product Labeler Information

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

Labeler Name: Aidarex Pharmaceuticals Llc
Labeler Code: 33261
Start Marketing Date: 07-21-2011 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

Acetaminophen

Acetaminophen is pronounced as (a set a mee' noe fen)

Why is acetaminophen medication prescribed?
Acetaminophen is used to relieve mild to moderate pain from headaches, muscle aches, menstrual periods, colds and sore throats, toothaches, backaches, and reactions to va...
[Read More]
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.

Acetadryl 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 Ingredients

Acetaminophen 500 mg and Diphenhydramine HCl 25 mg

Purpose

Pain Reliever/Nightime Sleep Aid

Uses

Temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness.

Warnings

  • Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 2 caplets in 24 hours, which is the maximum daily amount for this product
  • With other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product

Do Not Use

  • With any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • In children under 12 years of age
  • With any other product containing diphenhydramine, even one used on skin
  • If you are allergic to acetaminophen or any of the inactive ingredients in this product

Ask A Doctor Before Use If You Have

  • Liver disease
  • A breathing problem such as emphysema or chronic bronchitis
  • Difficulty in urination due to enlargement of the prostate gland
  • Glaucoma

Ask A Doctor Or Pharmacist Before Use If You Are

  • Taking the blood thinning drug warfarin
  • Taking sedatives or tranquilizers

When Using This Product

  • Drowsiness will occur
  • Avoid alcoholic drinks
  • 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 a serious underlying medical illness.
  • Pain gets worse or lasts more than 10 days
  • Fever gets worse or lasts more than 3 days
  • New symptoms occur
  • Redness or swelling is presentThese could be signs of a serious condition.

If Pregnant Or Breast-Feeding,

Ask a health professional before use.

Overdose Warning:

Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

  • Do not take more than directed (see overdose warning)Adults and children 12 years of age or over:Take 2 caplets at bedtime if needed, or as directed by a doctorChildren under 12 years: Do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage.

Other Information

  • Store at room temperature

Inactive Ingredients

Croscarmellose Sodium, Crospovidone, FD&C Blue #1, Hydroxypropyl Cellulose, Hypromellose, Magnesium Stearate, Microcrystalline Cellulose, Povidone, Pregelatinized Starch, Propylene Glycol, Silica, Sodium Starch Glycolate, Stearic Acid and Titanium Dioxide.

* Please review the disclaimer below.