Tension Headache Relief (acetaminophen 500mg And Caffeine 65mg)

Tension Headache Relief (acetaminophen 500mg And Caffeine 65mg)
SPL v3
SPL
SPL Set ID ea4e50e9-2c4d-4e58-b2cb-ab23e91fd50e
Route
ORAL
Published
Effective Date 2024-08-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (500 mg) Caffeine (65 mg)
Inactive Ingredients
Croscarmellose Sodium Polyethylene Glycol, Unspecified Polyvinyl Alcohol, Unspecified Talc Microcrystalline Cellulose Silicon Dioxide Starch, Corn Titanium Dioxide D&c Red No. 27 Fd&c Blue No. 2 Magnesium Stearate Stearic Acid Fd&c Yellow No. 6

Identifiers & Packaging

Pill Appearance
Imprint: None Shape: capsule Color: red Size: 28 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-07-30

Description

Acetaminophen 500mg Caffeine 65 mg

Purpose

Acetaminophen 500mg................................Pain reliever Caffeine 65mg............................................Pain reliever aid


Medication Information

Purpose

Acetaminophen 500mg................................Pain reliever

Caffeine 65mg............................................Pain reliever aid

Description

Acetaminophen 500mg Caffeine 65 mg

Uses:

temporarily relieves minor aches and pains due to:

•headache

•muscular aches

Section 50565-1

KEEP OUT OF REACH OF CHILDREN.  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.

Section 50568-5

Ask a doctor or pharmacist before use if you are

•taking the blood thinning drug warfarin

Section 50569-3

Ask a doctor before use if

•you have liver disease

Section 51945-4

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Warnings:

ALLERGY 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.

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

•no 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 product

Caffeine 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 heartbeat.

DO NOT USE:

•if you have ever had an allergic reaction 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.

Directions
  • 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 hours
  • chlidren 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.

Inactive Ingredients

Colloidal Silicon Dioxide, Croscarmellose Sodium, D & C Red # 27, F D & C yellow # 6, F D & C Blue # 2, Microcrystalline Cellulose, Magnesium Stearate, Polyethylene Glycol, Polyvinyl Pyrrolidone, Pregelatinized Starch, Polyvinyl Alcohol, Stearic Acid Powder, Titanium Dioxide, Talc.

Questions Or Comments?

Call 1 (718) 337-8733 or visit [email protected]

Stop Use and Ask Doctor If 

■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 days. These could be signs of a serious condition.

Active Ingredients  (in Each Caplet)

Acetaminophen 500mg

Caffeine 65 mg


Structured Label Content

Uses:

temporarily relieves minor aches and pains due to:

•headache

•muscular aches

Section 50565-1 (50565-1)

KEEP OUT OF REACH OF CHILDREN.  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.

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are

•taking the blood thinning drug warfarin

Section 50569-3 (50569-3)

Ask a doctor before use if

•you have liver disease

Section 51945-4 (51945-4)

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Purpose

Acetaminophen 500mg................................Pain reliever

Caffeine 65mg............................................Pain reliever aid

Warnings:

ALLERGY 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.

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

•no 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 product

Caffeine 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 heartbeat.

DO NOT USE:

•if you have ever had an allergic reaction 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.

Directions (DIRECTIONS)
  • 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 hours
  • chlidren under 12 years: ask a doctor
Other Information (OTHER INFORMATION)

•store at 20°-25°C (68°-77°F)

•close cap tightly after use

•read all product information before using.

Inactive Ingredients (INACTIVE INGREDIENTS)

Colloidal Silicon Dioxide, Croscarmellose Sodium, D & C Red # 27, F D & C yellow # 6, F D & C Blue # 2, Microcrystalline Cellulose, Magnesium Stearate, Polyethylene Glycol, Polyvinyl Pyrrolidone, Pregelatinized Starch, Polyvinyl Alcohol, Stearic Acid Powder, Titanium Dioxide, Talc.

Questions Or Comments? (QUESTIONS OR COMMENTS?)

Call 1 (718) 337-8733 or visit [email protected]

Stop Use and Ask Doctor If  (Stop use and ask doctor if )

■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 days. These could be signs of a serious condition.

Active Ingredients  (in Each Caplet) (Active Ingredients  (in each caplet))

Acetaminophen 500mg

Caffeine 65 mg


Advanced Ingredient Data


Raw Label Data

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