EXTRA STRENGTH HEADACHE POWDER powder

Extra Strength Headache Powder by

Drug Labeling and Warnings

Extra Strength Headache Powder by is a Otc medication manufactured, distributed, or labeled by 9 Rx LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

FAST PAIN RELIEF EXTRA STRENGTH HEADACHE POWDER

ACETAMINOPHEN / ASPIRIN (NSAID) / CAFFEINE
PAIN RELIEVER / PAIN RELIEVER AID
50 POUCHES CONTAINING 2 PACKS EACH

Drug Facts

SPL UNCLASSIFIED SECTION

Active ingredients

(in each powder):
Acetaminophen 260 mg
Aspirin (NSAID*) 520 mg
Caffeine 32.5 mg
*nonsteroidal anti-inflammatory drug

Purposes

Pain reliever

Pain reliever

Pain reliver aid

Uses

temporarily relives minor aches and pains due to:

• headache ▪ minor arthritis pain
• muscular aches ▪ colds

temporarily reduces fever

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.

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.

Keep out of reach of children.

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.

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)

Inactive ingredient

lactose monohydrate, potassium chloride

QUESTIONS

Questions?
1-800-940-9619 weekdays

Principal package Label

INGREDIENTS AND APPEARANCE

EXTRA STRENGTH HEADACHE POWDER 
extra strength headache powder powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84800-041
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	260 mg
ASPIRIN (UNII: R16CO5Y76E) (ACETYLSALICYLIC ACID - UNII:R16CO5Y76E)	ASPIRIN	520 mg
CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E)	CAFFEINE	32.5 mg

Inactive Ingredients
Ingredient Name	Strength
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84800-041-50	50 in 1 BOX	10/25/2024
1	NDC: 84800-041-01	1 in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M	10/25/2024

Labeler - 9 Rx LLC (119266303)

Registrant - 9 Rx LLC (119266303)