NDC 0067-8147 Excedrin Pm Triple Action Caplets And Excedrin Tension Headache

NDC Product Code 0067-8147

NDC CODE: 0067-8147

Proprietary Name: Excedrin Pm Triple Action Caplets And Excedrin Tension Headache 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.

NDC Code Structure

  • 0067 - Glaxosmithkline Consumer Healthcare Holdings (us) Llc
    • 0067-8147 - Excedrin Pm Triple Action Caplets And Excedrin Tension Headache

NDC 0067-8147-01

Package Description: 1 KIT in 1 PACKAGE, COMBINATION * 1 BOTTLE in 1 CARTON (0067-2056-24) > 24 TABLET, COATED in 1 BOTTLE * 1 BOTTLE in 1 CARTON (0067-8139-02) > 100 TABLET, FILM COATED in 1 BOTTLE

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

NDC Product Information

Excedrin Pm Triple Action Caplets And Excedrin Tension Headache with NDC 0067-8147 is a product labeled by Glaxosmithkline Consumer Healthcare Holdings (us) Llc. The generic name of Excedrin Pm Triple Action Caplets And Excedrin Tension Headache is . The product's dosage form is and is administered via form.

Labeler Name: Glaxosmithkline Consumer Healthcare Holdings (us) Llc

Dosage Form: -

Product Type: 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.

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.

  • BENZOIC ACID (UNII: 8SKN0B0MIM)
  • CALCIUM CARBONATE (UNII: H0G9379FGK)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 2165RE0K14)
  • HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • MALTODEXTRIN (UNII: 7CVR7L4A2D)
  • MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
  • POLYDEXTROSE (UNII: VH2XOU12IE)
  • POLYSORBATE 80 (UNII: 6OZP39ZG8H)
  • POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
  • STARCH, CORN (UNII: O8232NY3SJ)
  • MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • TALC (UNII: 7SEV7J4R1U)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
  • ZINC STEARATE (UNII: H92E6QA4FV)
  • BENZOIC ACID (UNII: 8SKN0B0MIM)
  • D&C RED NO. 27 ALUMINUM LAKE (UNII: ZK64F7XSTX)
  • FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
  • FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
  • POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
  • POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
  • POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
  • STARCH, CORN (UNII: O8232NY3SJ)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • 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: Glaxosmithkline Consumer Healthcare Holdings (us) Llc
Labeler Code: 0067
Start Marketing Date: 06-01-2017 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 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.

Excedrin Pm Triple Action Caplets And Excedrin Tension Headache Product Label Images

Excedrin Pm Triple Action Caplets And Excedrin Tension Headache 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 (In Each Caplet)

Acetaminophen 250 mgAspirin 250 mg (NSAID*)Diphenhydramine citrate 38 mg*nonsteroidal anti-inflammatory drug

Acetaminophen 500 mgCaffeine 65 mg

Purposes

Pain RelieverPain RelieverNighttime sleep-aid

Pain reliever Pain reliever aid

Uses

  • •for the temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness

  • •temporarily relieves minor aches and pain due to: oheadachemuscular aches

Warnings

  • Reye’s syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye’s syndrome, a rare but serious illness.Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include: •skin reddening •blisters •rashIf a skin reaction occurs, stop use and seek medical help right away.Allergy alert: Aspirin may cause a severe allergic reaction which may include: •hives •facial swelling •asthma (wheezing) •shockLiver 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 •with other drugs containing acetaminophen •3 or more alcoholic drinks every day while using this productStomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you •are age 60 or older •have had stomach ulcers or bleeding problems •take a blood thinning (anticoagulant) or steroid drug •take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others) •have 3 or more alcoholic drinks every day while using this product •take more or for a longer time than directed

  • Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include: •skin reddening •blisters •rashIf a skin reaction occurs, stop use and seek medical help right away.Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take •more than 6 caplets in 24 hours, which is the maximum daily amount •with other drugs containing acetaminophen •3 or more alcoholic drinks every day while using this productCaffeine warning: The recommended dose of this product contains about as much caffeine as a cup of coffee. Limit the use of caffeine-containing medications, foods, or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and occasionally, rapid heart beat

Do Not Use

  • •if you have ever had an allergic reaction to acetaminophen, aspirin or any other pain reliever/fever reducer •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 are allergic to acetaminophen •with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

Ask A Doctor Before Use If

  • •you have liver disease •stomach bleeding warning applies to you •you have a history of stomach problems, such as heartburn •you have high blood pressure, heart disease, liver cirrhosis, or kidney disease •you are taking a diuretic •you have asthma •you have glaucoma •you have a breathing problem such as emphysema or chronic bronchitis •you have trouble urinating due to an enlarged prostate gland

  • •you have liver disease

Ask A Doctor Or Pharmacist Before Use If You Are

  • Taking •a prescription drug for: •diabetes •gout •arthritis •any other drug, or are under a doctor’s care for any serious condition •any product that contains aspirin, acetaminophen, or any other pain reliever/fever reducer •sedatives or tranquilizers

Taking the blood thinning drug warfarin

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

  • •an allergic reaction occurs. Seek medical help right away. •you experience any of the following signs of stomach bleeding: •feel faint •vomit blood •have bloody or black stools •have stomach pain that does not get better •sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness. •pain gets worse or last for more than 10 days •painful area is red or swollen •ringing in the ears or a loss of hearing occurs •any new symptoms occurThese could be signs of a serious condition

  • •any new symptoms occur •painful area is red or swollen •pain gets worse or lasts for more than 10 days •fever gets worse or lasts for more than 3 daysThese could be signs of a serious condition

If Pregnant Or Breast-Feeding,

Ask a health professional before use. It is especially important not to use aspirin during the last three months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

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. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

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 use more than directed •do not use in children under 12 years of age •adults and children 12 years of age and over: take 2 caplets at bedtime, with a full glass of water •do not take more than 2 caplets in 24 hours, unless directed by a doctor

  • •do not use more than directed •adults and children 12 years and over; take 2 caplets every 6 hours; not more than 6 caplets in 24 hourschildren under 12 years: ask a doctor

Other Information

  • •store at 20°-25°C (68°-77°F). •close cap tightly after use. •read all product information before using. Keep this box for important information.

  • •store at 20°-25°C (68°-77°F) •close cap tightly after useread all product information before using. Keep this box for important information.

Inactive Ingredients

Benzoic acid, calcium carbonate, FD&C blue#1 aluminum lake, hydroxypropyl cellulose low substituted, hypromellose, magnesium stearate, maltodextrin, medium-chain triglycerides, polydextrose, polysorbate 80, povidone, pregelatinized corn starch, silicified microcrystalline cellulose, stearic acid, talc, titanium dioxide, yellow iron oxide, zinc stearate

Benzoic acid, D&C red #27 aluminum lake, FD&C blue #2 aluminum lake, FD&C yellow #6 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, stearic acid, talc, titanium dioxide

* Please review the disclaimer below.