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| Product NDC Code | 69842-308 | ||||
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| Drug Name | Acetaminophen diphenhydramine hcl |
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| Type | Generic | ||||
| Pharm Class | Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC] |
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| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | TABLET | ||||
| Application Number | part343 | ||||
| Labeler Name | CVS PHARMACY, INC | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Overdosage of Acetaminophen Diphenhydramine HCl
Information about signs, symptoms, and laboratory findings of acute ovedosage and the general principles of overdose treatment.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 (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.
Active ingredient
A list of the active, medicinal ingredients in the drug product.ACETAMINOPHEN GELCAPS Active ingredient (in each Gelcap) Acetaminophen, USP 500 mg
ACETAMINOPHEN PM GELCAPS Active ingredient (in each gelcap) Acetaminophen, USP 500 mg Diphenhydramine HCl, USP 25 mg
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.Directions ■ do not take more than directed adults and children 12 years and over ■ take 2 gelcaps every 6 hours while symptoms last ■ do not take more than 6 gelcaps in 24 hours, unless directed by a doctor ■ do not take more than 10 days unless directed by a doctor children under 12 years ■ ask a doctor
Directions ■ do not take more than directed (see overdose warning) adults and children 12 years and over ■ take 2 gelcaps at bedtime ■ do not take more than 2 gelcaps of this product in 24 hours children under 12 years ■ do not use
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients ammonium hydroxide, black iron oxide, black iron oxide irradiated, colloidal silicon dioxide, croscarmellose sodium, gelatin, hydroxypropyl cellulose, hydroxypropyl methyl cellulose, hypromellose, iron oxide red, isopropyl alcohol, n-butyl alcohol, polyethylene glycol, povidone, pregelatinized starch, propylene glycol, shellac glaze, stearic acid, titanium dioxide, yellow iron oxide.
Inactive ingredients colloidal silicon dioxide, croscarmellose sodium, FD&C blue #2, FD&C red #40, FD&C yellow #6, gelatin, hydroxypropyl cellulose, hypromellose, isopropyl alcohol, microcrystalline cellulose, n-butyl alcohol, povidone, pregelatinized starch, propylene glycol, shellac glaze, stearic acid, titanium dioxide, triacetin.
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Uses ■ temporarily relieves minor aches and pains due to: ■ headache ■ muscular aches ■ backache ■ minor pain of arthritis ■ the common cold ■ toothache ■ premenstrual and menstrual cramps ■ temporarily reduces fever
Uses temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness
Purpose
Information about the drug product’s indications for use.Purpose Pain reliever/fever reducer
Purposes Pain reliever Nighttime sleep aid
Spl product data elements
Usually a list of ingredients in a drug product.Acetaminophen Diphenhydramine HCl Acetaminophen Diphenhydramine HCl HYDROXYPROPYL CELLULOSE, UNSPECIFIED PROPYLENE GLYCOL FERRIC OXIDE YELLOW GELATIN HYPROMELLOSE, UNSPECIFIED AMMONIA SILICON DIOXIDE STEARIC ACID TRIACETIN FERROSOFERRIC OXIDE BUTYL ALCOHOL POVIDONE STARCH, CORN SHELLAC TITANIUM DIOXIDE CROSCARMELLOSE SODIUM CROSCARMELLOSE FERRIC OXIDE RED ISOPROPYL ALCOHOL POLYETHYLENE GLYCOL, UNSPECIFIED ACETAMINOPHEN ACETAMINOPHEN DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE FD&C YELLOW NO. 6 FOOD YELLOW 3 FREE ACID CELLULOSE, MICROCRYSTALLINE Encapsulated gray color tablets with one red opaque and one blue-gray opaque hard gelatin shells Encapsulated gray color tablets with dark blue opaque and light blue opaque hard gelatin shells G1;G3
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.100 count (50+50)
Ask doctor
Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.Ask a doctor before use if you have liver disease.
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
Ask doctor or pharmacist
Information about when a doctor or pharmacist should be consulted about drug/drug or drug/food interactions before using a drug product.Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin.
Ask a doctor or pharmacist before use if you are ■ taking the blood thinning drug warfarin ■ taking sedatives or tranquilizers
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.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 ■ if you have ever had an allergic reaction to this product or any of its ingredients
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
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of the reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Keep out of the reach of children. Keep out of the reach of children.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other information ■ store at 20°-25°C (68°-77°F). See USP Controlled Room Temperature ■ avoid high humidity ■ see end panel for lot number and expiration date
Other information ■ store between 20°-25°C (68°-77°F). See USP Controlled Room Temperature. ■ see end panel for lot number and expiration date
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or comments? call 1-877-770-3183 Mon-Fri 9:00 AM to 4:30 PM EST.
Questions or comments? call 1-877-770-3183 Mon-Fri 9:00 AM to 4:30 PM EST.
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.Stop use and ask a doctor if ■ pain gets worse or lasts more than 10 days ■ fever gets worse or lasts more than 3 days ■ new symptoms occur ■ redness or swelling is present These could be signs of a serious condition.
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 ■ fever gets worse or lasts more than 3 days ■ redness or swelling is present ■ new symptoms occur These could be signs of a serious condition.
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.When using this product ■ drowsiness will occur ■ avoid alcoholic drinks ■ do not drive a motor vehicle or operate machinery
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast-feeding, ask a health professional before use.
If pregnant or breast-feeding, ask a health professional before use.
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.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.
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.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API