Lly 224

Lly 224
SPL v1
SPL
SPL Set ID 27fd288e-c07a-617f-e063-6394a90a17a4
Route
ORAL
Published
Effective Date 2013-05-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (500 mg) Diphenhydramine (25 mg)
Inactive Ingredients
Starch, Corn Povidone Fd&c Blue No. 1 Croscarmellose Sodium Hypromelloses Cellulose, Microcrystalline Polyethylene Glycol, Unspecified Stearic Acid Titanium Dioxide Silicon Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: AZ267 Shape: capsule Color: blue Size: 18 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-07-01

Description

Acetaminophen 500 mg Diphenhydramine HCI 25 mg

Purpose

Pain Reliever Sleep aid


Medication Information

Purpose

Pain Reliever Sleep aid

Description

Acetaminophen 500 mg Diphenhydramine HCI 25 mg

Uses

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

Section 50565-1

Keep out of reach of children.

Overdose warning:
In case of overdose, get medical help or contact a Poison

Control Center right away. (1-800-222-1222). Quick medical attention is critical for

adults as well as for children even if you do not notice any signs or symptoms.

Purposes

Pain Reliever

Sleep aid

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 product

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.

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 ingredients

Ask a doctor before use if you have • liver disease • a breathing problem such as emphysema or chronic bronchitis • glaucoma • difficulty urinating due to an enlarged prostate gland

Ask a doctor or pharmacist before use if you are taking • the blood thinning drug warfarin

• sedatives or tranquilizers

When using this product • drowsiness will occur • do not drive a motor vehicle or operate machinery after use • avoid alcoholic drinks

Stop use and ask a doctor if • sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness. • pain gets worse or lasts for more that 10 days • fever gets worse or lasts more than 3 days • new symptoms occur • redness or swelling is present.These may be signs of a serious condition.

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

Directions

do not take more than directed (see overdose warning)

Adults and Children 12 years and over Take 2 caplets at bedtime.

Do not take more than 2 caplets of this product in 24 hours.
Children under 12 years Do not use.

Package Label

Other Information

• store at room temperature

Active Ingredients

Acetaminophen 500 mg

Diphenhydramine HCI 25 mg

Inactive Ingredients

croscarmellose sodium, FD&C blue #1 lake, hypromellose, microcrystalline cellulose, PEG, povidone, silica, starch, stearic acid, titanium dioxide

Questions Or Comments?

1-800-540-3765


Structured Label Content

Uses

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

Section 50565-1 (50565-1)

Keep out of reach of children.

Overdose warning:
In case of overdose, get medical help or contact a Poison

Control Center right away. (1-800-222-1222). Quick medical attention is critical for

adults as well as for children even if you do not notice any signs or symptoms.

Purposes

Pain Reliever

Sleep aid

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 product

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.

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 ingredients

Ask a doctor before use if you have • liver disease • a breathing problem such as emphysema or chronic bronchitis • glaucoma • difficulty urinating due to an enlarged prostate gland

Ask a doctor or pharmacist before use if you are taking • the blood thinning drug warfarin

• sedatives or tranquilizers

When using this product • drowsiness will occur • do not drive a motor vehicle or operate machinery after use • avoid alcoholic drinks

Stop use and ask a doctor if • sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness. • pain gets worse or lasts for more that 10 days • fever gets worse or lasts more than 3 days • new symptoms occur • redness or swelling is present.These may be signs of a serious condition.

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

Directions

do not take more than directed (see overdose warning)

Adults and Children 12 years and over Take 2 caplets at bedtime.

Do not take more than 2 caplets of this product in 24 hours.
Children under 12 years Do not use.

Package Label (package Label)

Other Information (Other information)

• store at room temperature

Active Ingredients

Acetaminophen 500 mg

Diphenhydramine HCI 25 mg

Inactive Ingredients (Inactive ingredients)

croscarmellose sodium, FD&C blue #1 lake, hypromellose, microcrystalline cellulose, PEG, povidone, silica, starch, stearic acid, titanium dioxide

Questions Or Comments? (Questions or comments?)

1-800-540-3765


Advanced Ingredient Data


Raw Label Data

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