Aero Extra Strength Heache Powder

Aero Extra Strength Heache Powder
SPL v1
SPL
SPL Set ID 5199ad9c-43f8-4263-9145-8ae8e256112e
Route
ORAL
Published
Effective Date 2024-11-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (260 mg) Acetylsalicylic Acid (520 mg) Caffeine (32.5 mg)
Inactive Ingredients
Lactose Monohydrate Potassium Chloride

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-10-25

Description

FAST PAIN RELIEF EXTRA STRENGTH HEADACHE POWDER ACETAMINOPHEN / ASPIRIN (NSAID) / CAFFEINE PAIN RELIEVER / PAIN RELIEVER AID 50 POUCHES CONTAINING 2 PACKS EACH Drug Facts

Purpose

Pain reliever Pain reliever Pain reliver aid


Medication Information

Purpose

Pain reliever Pain reliever Pain reliver aid

Description

FAST PAIN RELIEF EXTRA STRENGTH HEADACHE POWDER ACETAMINOPHEN / ASPIRIN (NSAID) / CAFFEINE PAIN RELIEVER / PAIN RELIEVER AID 50 POUCHES CONTAINING 2 PACKS EACH Drug Facts

Uses

temporarily relives minor aches and pains due to:

  • headache ▪ minor arthritis pain
  • muscular aches ▪ colds

temporarily reduces fever

Section 42229-5

FAST PAIN RELIEF EXTRA STRENGTH HEADACHE POWDER

ACETAMINOPHEN / ASPIRIN (NSAID) / CAFFEINE

PAIN RELIEVER / PAIN RELIEVER AID

50 POUCHES CONTAINING 2 PACKS EACH

Drug Facts

Section 53413-1

Questions?

1-800-940-9619 weekdays

Purposes

Pain reliever

Pain reliever

Pain reliver aid

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: Aspirin may cause severe allergic reaction which may include:

• hives • facial swelling • shock • asthma (wheezing).

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

  • more than 4 powders in 24 hours, which is the maximum daily amount
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product

Stomach bleeding warning: This product contains a 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 non-prescription 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.
Do Not Use
  • if you have ever had an allergic reaction to 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.
Directions:
  • do not take more than directed (see overdose warning)
  • adults and children 12 years and over: place 1 powder on tongue every 6 hours, while symptoms persist. Drink a full glass of water with each  dose or may stir powder into a glass of water or other liquid.
  • do not take more than 4 powders in 24 hours unless directed by a doctor.
  • Children under 12 years of age: ask a doctor.
Other Information

  • each powder contains: potassium 51 mg
  • store below 25°C (77°F)
Overdose Warning:

Taking more than the recommended dose can cause serious health problems. In case of overdose, get medical help or contact a Poison Control

Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Active Ingredients

(in each powder):

Acetaminophen 260 mg

Aspirin (NSAID*) 520 mg

Caffeine 32.5 mg

*nonsteroidal anti-inflammatory drug

Inactive Ingredient

lactose monohydrate, potassium chloride

Principal Package Label

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

Ask a doctor or pharmacist before use if you are taking a prescription drug for diabetes, gout, or arthritis the blood thinning drug warfarin.

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 stool  have stomach pain that does not get better

  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • any new symptoms appear
  • ringing in the ears or a loss of hearing occurs

These 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 3 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.


Structured Label Content

Uses

temporarily relives minor aches and pains due to:

  • headache ▪ minor arthritis pain
  • muscular aches ▪ colds

temporarily reduces fever

Section 42229-5 (42229-5)

FAST PAIN RELIEF EXTRA STRENGTH HEADACHE POWDER

ACETAMINOPHEN / ASPIRIN (NSAID) / CAFFEINE

PAIN RELIEVER / PAIN RELIEVER AID

50 POUCHES CONTAINING 2 PACKS EACH

Drug Facts

Section 53413-1 (53413-1)

Questions?

1-800-940-9619 weekdays

Purposes

Pain reliever

Pain reliever

Pain reliver aid

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: Aspirin may cause severe allergic reaction which may include:

• hives • facial swelling • shock • asthma (wheezing).

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

  • more than 4 powders in 24 hours, which is the maximum daily amount
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product

Stomach bleeding warning: This product contains a 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 non-prescription 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.
Do Not Use (Do not Use)
  • if you have ever had an allergic reaction to 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.
Directions:
  • do not take more than directed (see overdose warning)
  • adults and children 12 years and over: place 1 powder on tongue every 6 hours, while symptoms persist. Drink a full glass of water with each  dose or may stir powder into a glass of water or other liquid.
  • do not take more than 4 powders in 24 hours unless directed by a doctor.
  • Children under 12 years of age: ask a doctor.
Other Information

  • each powder contains: potassium 51 mg
  • store below 25°C (77°F)
Overdose Warning: (Overdose warning:)

Taking more than the recommended dose can cause serious health problems. In case of overdose, get medical help or contact a Poison Control

Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Active Ingredients (Active ingredients)

(in each powder):

Acetaminophen 260 mg

Aspirin (NSAID*) 520 mg

Caffeine 32.5 mg

*nonsteroidal anti-inflammatory drug

Inactive Ingredient (Inactive ingredient)

lactose monohydrate, potassium chloride

Principal Package Label (Principal package Label)

Ask A Doctor Before Use If (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

Ask a doctor or pharmacist before use if you are taking a prescription drug for diabetes, gout, or arthritis the blood thinning drug warfarin.

Stop Use and Ask A Doctor If (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 stool  have stomach pain that does not get better

  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • any new symptoms appear
  • ringing in the ears or a loss of hearing occurs

These could be signs of a serious condition.

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use. It is especially important not to use aspirin during the last 3 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.


Advanced Ingredient Data


Raw Label Data

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