Extra Strength Night Time Pain Medicine ACETAMINOPHEN DIPHENHYDRAMINE HCL GERI-CARE PHARMACEUTICAL CORP FDA Approved Uses for the temporary relief of occasional headaches and minor ache and pains along with accompanying sleeplessness
FunFoxMeds box
Substance Acetaminophen
Route
ORAL
Applications
M013

Drug Facts

Composition & Profile

Active Ingredients
Active Ingredients Acetaminophen 500 mg Diphenhydramine HCI 25 mg
Inactive Ingredients
Inactive ingredients cellulose croscarmellose sodium FD&C blue #1 lake FD&C blue #2 lake hypromellose magnesium stearate PEG polyvinyl alcohol povidone purified water silicon dioxide sodium starch glycolate starch talc titanium dioxide
Strengths
500 mg 25 mg
Treats Conditions
Uses For The Temporary Relief Of Occasional Headaches And Minor Ache And Pains Along With Accompanying Sleeplessness

Identifiers & Packaging

Container Type UNKNOWN
UPC
0357896224059
UNII
362O9ITL9D TC2D6JAD40
Packaging

package Label 1

Package Descriptions
  • package Label 1

Overview

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

Indications & Usage

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

Dosage & Administration

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

Warnings & Precautions
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. 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.
Purpose

Purposes Pain Reliever Sleep aid

Keep Out of Reach of Children

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.

Storage & Handling

Other information • store at controlled room temperature 20-25 °C (68-77° F)

Questions

Questions or comments? 1-800-540-3765


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