Counteract Pm Content Of Label

Counteract Pm Content Of Label
SPL v2
SPL
SPL Set ID 7f9a0062-0e86-1deb-e053-2a91aa0a9188
Route
ORAL
Published
Effective Date 2016-05-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (25 mg) Acetaminophen (500 mg)
Inactive Ingredients
Microcrystalline Cellulose Sodium Starch Glycolate Type A Potato Hypromellose, Unspecified Silicon Dioxide Stearic Acid Anhydrous Citric Acid Pyrrolidone Sodium Carbonate Magnesium Stearate Magnesium Silicate Maltodextrin Calcium Carbonate Croscarmellose Anhydrous Lactose Medium-chain Triglycerides Starch, Corn

Identifiers & Packaging

Pill Appearance
Shape: capsule Color: white Size: 18 mm Score: 1
Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2016-05-02

Description

Acetaminophen 500 mg Diphenhydramine HCl 25 mg

Purpose

Pain reliever Nighttime sleep-aid


Medication Information

Warnings and Precautions

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

Keep out of reach of children.

Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. 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.

Purpose

Pain reliever

Nighttime sleep-aid

Description

Acetaminophen 500 mg Diphenhydramine HCl 25 mg

Uses

temporary relief of occassional headaches, minor aches, and pains with accompanying sleeplessness

Section 50565-1

Keep out of reach of children

Section 51945-4

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, which is the maimum daily amount
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product
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.

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 are allergic to acetaminophen or any of the ingredients in this product
Other Information
  • store at controlled room temperature 15-30 oC (59-86 oF)
  • see end flap for expiration date and lot number
Active Ingredients

Acetaminophen 500 mg

Diphenhydramine HCl 25 mg

Inactive Ingredients

calcium carbonate, corn starch, citric acid, croscarmellose sodium, hypromellose, lactose, magnesium silicate,

magnesium stearate, maltodextrin, microcrystalline cellulose, medium-chain triglyceride, polyvinylpyrrolidone, pregelatinized starch, silicon dioxide, sodium carbonate, sodium starch glycolate, stearic acid.

Questions Or Comments?

If you have any questions or comments, or to report an adverse even, please contact 1-800-282-3000.

When Using This Product
  • drowsiness will occur
  • avoid alcoholic beverages
  • do not drive a motor vehicle or operate machinery
Stop Use and Ask A Doctor If
  • sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a searious underlying medical illness.
  • new symptoms occur
  • redness or swelling is present
  • pain gets worse of lasts more than 10 days
  • fever gets worse or lasts more than 3 days

These could be signs of a serious condition

Ask A Doctor Or Pharmacist Before Use If You Are
  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers
Do Not Take This Product Unless Directed By A Doctor If You Have
  • glaucoma
  • trouble urinating due to an enlarged prostate gland
  • liver disease
  • a breathing problem such as emphysema or chronic bronchitis

Structured Label Content

Uses

temporary relief of occassional headaches, minor aches, and pains with accompanying sleeplessness

Warnings and Precautions (34071-1)

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

Keep out of reach of children.

Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. 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.

Section 50565-1 (50565-1)

Keep out of reach of children

Section 51945-4 (51945-4)

Purpose

Pain reliever

Nighttime 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, which is the maimum daily amount
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product
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.

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 are allergic to acetaminophen or any of the ingredients in this product
Other Information
  • store at controlled room temperature 15-30 oC (59-86 oF)
  • see end flap for expiration date and lot number
Active Ingredients (Active ingredients)

Acetaminophen 500 mg

Diphenhydramine HCl 25 mg

Inactive Ingredients (Inactive ingredients)

calcium carbonate, corn starch, citric acid, croscarmellose sodium, hypromellose, lactose, magnesium silicate,

magnesium stearate, maltodextrin, microcrystalline cellulose, medium-chain triglyceride, polyvinylpyrrolidone, pregelatinized starch, silicon dioxide, sodium carbonate, sodium starch glycolate, stearic acid.

Questions Or Comments? (Questions or comments?)

If you have any questions or comments, or to report an adverse even, please contact 1-800-282-3000.

When Using This Product (When using this product)
  • drowsiness will occur
  • avoid alcoholic beverages
  • do not drive a motor vehicle or operate machinery
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a searious underlying medical illness.
  • new symptoms occur
  • redness or swelling is present
  • pain gets worse of lasts more than 10 days
  • fever gets worse or lasts more than 3 days

These could be signs of a serious condition

Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)
  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers
Do Not Take This Product Unless Directed By A Doctor If You Have (Do not take this product unless directed by a doctor if you have)
  • glaucoma
  • trouble urinating due to an enlarged prostate gland
  • liver disease
  • a breathing problem such as emphysema or chronic bronchitis

Advanced Ingredient Data


Raw Label Data

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