conrx™ pm

conrx™ pm
SPL v1
SPL
SPL Set ID 7d0a616e-0dae-46fc-be98-107880f3b67b
Route
oral
Published
Effective Date 2013-02-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
acetaminophen (500 mg) diphenhydramine (25 mg)
Inactive Ingredients
carnauba wax fd&c blue no. 1 fd&c blue no. 2 aluminum oxide hypromelloses magnesium stearate polyethylene glycol 6000 polysorbate 80 powdered cellulose starch, corn propylene glycol shellac sodium citrate sodium starch glycolate type a corn titanium dioxide

Identifiers & Packaging

Pill Appearance
Imprint: CRX Shape: oval Color: blue Size: 18 mm Score: 2
Marketing Status
otc monograph final active Since 2013-02-15

Description

Drug Facts


Medication Information

Uses

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

Directions

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 this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage

Other Information
  • store between 20-25°C (68-77°F)
  • do not use if pouch is torn or open
  • see side panel for lot number and expiration date
Inactive Ingredients

croscarmellose sodium, FD&C blue #1, hypromellose, microcrystalline cellulose, polyethylene glycol, povidone, starch, stearic acid, titanium dioxide. May contain polyvinyl alcohol, silicon dioxide, sodium starch glycolate, talc.

Description

Drug Facts

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.

Section 53414-9

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

Section 55105-1
Active ingredients (in each caplet) Purpose
Acetaminophen 500 mg Pain reliever
Diphenhydramine HCl 25 mg Nighttime sleep aid
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 product containing diphenhydramine, even one used on skin n in children under 12 years of age
  • if you have ever had an allergic reaction to this product or any of its ingredients
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
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.

Questions Or Comments?

1-800-570-8650

When Using This Product
  • drowsiness will occur
  • avoid alcoholic drinks
  • 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 serious underlying medical illness.
  • pain gets worse or lasts more than 10 days n fever gets worse or lasts more than 3 days
  • redness or swelling is present n new symptoms occur

These could be signs of a serious condition.

Ask A Doctor Before Use If You Have
  • liver disease
  • a breathing problem such as emphysema or chronic bronchitis
  • trouble urinating due to an enlarged prostate gland
  • glaucoma
Principal Display Panel 50 Pouch Box

See New Warnings Information & Directions

Compare to the Active Ingredients in

Tylenol PM
®*

ConRx™

PM

EXTRA

STRENGTH

Pain Reliever    Nighttime Sleep Aid

Acetaminophen, Diphenhydramine HCl

TO OPEN

PUSH IN TAB AND PULL OUT

Compare to the Active Ingredients in

Tylenol PM
®*

50 Pouches of 2 Caplets Each

Ask A Doctor Or Pharmacist Before Use If You Are
  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers

Structured Label Content

Uses

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

Directions

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 this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage

Other Information (Other information)
  • store between 20-25°C (68-77°F)
  • do not use if pouch is torn or open
  • see side panel for lot number and expiration date
Inactive Ingredients (Inactive ingredients)

croscarmellose sodium, FD&C blue #1, hypromellose, microcrystalline cellulose, polyethylene glycol, povidone, starch, stearic acid, titanium dioxide. May contain polyvinyl alcohol, silicon dioxide, sodium starch glycolate, talc.

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)
Active ingredients (in each caplet) Purpose
Acetaminophen 500 mg Pain reliever
Diphenhydramine HCl 25 mg Nighttime sleep aid
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 product containing diphenhydramine, even one used on skin n in children under 12 years of age
  • if you have ever had an allergic reaction to this product or any of its ingredients
Liver Warning (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
Overdose Warning (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.

Questions Or Comments? (Questions or comments?)

1-800-570-8650

When Using This Product (When using this product)
  • drowsiness will occur
  • avoid alcoholic drinks
  • 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 serious underlying medical illness.
  • pain gets worse or lasts more than 10 days n fever gets worse or lasts more than 3 days
  • redness or swelling is present n new symptoms occur

These could be signs of a serious condition.

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • liver disease
  • a breathing problem such as emphysema or chronic bronchitis
  • trouble urinating due to an enlarged prostate gland
  • glaucoma
Principal Display Panel 50 Pouch Box (PRINCIPAL DISPLAY PANEL - 50 Pouch Box)

See New Warnings Information & Directions

Compare to the Active Ingredients in

Tylenol PM
®*

ConRx™

PM

EXTRA

STRENGTH

Pain Reliever    Nighttime Sleep Aid

Acetaminophen, Diphenhydramine HCl

TO OPEN

PUSH IN TAB AND PULL OUT

Compare to the Active Ingredients in

Tylenol PM
®*

50 Pouches of 2 Caplets Each

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

Advanced Ingredient Data


Raw Label Data

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