NDC 13411-855 Acetamax Pm

Acetaminophen, Diphenhydramine Hcl

NDC Product Code 13411-855

NDC 13411-855-16

Package Description: 16 BLISTER PACK in 1 BOX > 1 TABLET, EFFERVESCENT in 1 BLISTER PACK

NDC 13411-855-20

Package Description: 20 BLISTER PACK in 1 BOX > 1 TABLET, EFFERVESCENT in 1 BLISTER PACK

NDC 13411-855-24

Package Description: 24 BLISTER PACK in 1 BOX > 1 TABLET, EFFERVESCENT in 1 BLISTER PACK

NDC Product Information

Acetamax Pm with NDC 13411-855 is a a human over the counter drug product labeled by Advanced Pharmaceutical Services, Inc. Dba Affordable Quality Pharmaceuticals. The generic name of Acetamax Pm is acetaminophen, diphenhydramine hcl. The product's dosage form is tablet, effervescent and is administered via oral form.

Labeler Name: Advanced Pharmaceutical Services, Inc. Dba Affordable Quality Pharmaceuticals

Dosage Form: Tablet, Effervescent - A solid dosage form containing mixtures of acids (e.g., citric acid, tartaric acid) and sodium bicarbonate, which release carbon dioxide when dissolved in water; it is intended to be dissolved or dispersed in water before administration.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Acetamax Pm Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • ACETAMINOPHEN 500 mg/1
  • DIPHENHYDRAMINE 25 mg/1

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.

  • ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • MANNITOL (UNII: 3OWL53L36A)
  • POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE)
  • POLYSORBATE 20 (UNII: 7T1F30V5YH)
  • POVIDONE K30 (UNII: U725QWY32X)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • SODIUM BICARBONATE (UNII: 8MDF5V39QO)
  • SODIUM CARBONATE (UNII: 45P3261C7T)
  • SODIUM CITRATE (UNII: 1Q73Q2JULR)
  • SUCRALOSE (UNII: 96K6UQ3ZD4)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.
  • Oral - Administration to or by way of the mouth.

Product Labeler Information

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

Labeler Name: Advanced Pharmaceutical Services, Inc. Dba Affordable Quality Pharmaceuticals
Labeler Code: 13411
FDA Application Number: part343 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 08-31-2020 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: 12-31-2021 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: N 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. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Acetamax Pm 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 mgDiphenhydramine HCl 25 mg

Purpose

  • Fever Reducer/Pain RelieverNighttime 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 4,000 mg of acetaminophen in 24 hours• with other drugs containing acetaminophen• 3 or more alcoholic drinks every day while using this productAllergy alert: acetaminophen may cause severe skin reactions. Symptoms may include:• skin reddening• blisters• rash If a skin reaction occurs, stop use and seek medical help right away.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.• with any other product containing diphenhydramine, even one used on skin• in children under 12 years of age• if you have ever had an allergic reaction to this product or any of its ingredientsAsk a doctor before use if you have• a sodium-restricted diet.• liver disease• a breathing problem such as emphysema or chronic bronchitis• trouble urinating due to an enlarged prostate gland• glaucomaAsk a doctor or pharmacist before use if you are• taking the blood thinning drug warfarin• taking sedatives or tranquilizersWhen using this product• drowsiness will occur• avoid alcoholic drinks• do not drive a motor vehicle or operate machineryStop use and ask a doctor if• sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness.• pain gets worse or lasts more than 10 days• fever gets worse or lasts more than 3 days• redness or swelling is present• new symptoms occur• These could be signs of a serious condition.If pregnant or breast-feeding,ask a health professional before use.Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away. 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 and over:• take 2 tablets fully dissolved in 8oz of water at  bedtime.• do not take more than 2 tablets of this product in 24 hoursChildren under 12 years: do not use

Other Information

Each tablet contains:Sodium 192 mgStore at room temperature 68 F-77 F (20oC-25oC)

Inactive Ingredients

Anhydrous citric acid, dimethicone, flavors, mannitol, polyethylene glycol 6000, polysorbate 20, povidone K30, silicon dioxide, sodium bicarbonate, sodium carbonate, sodium citrate, sucralose

* Please review the disclaimer below.