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| Product NDC Code | 69423-834 | ||||
|---|---|---|---|---|---|
| Drug Name | Vicks painquil pm pain reliever plus nighttime sleep-aid |
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| Type | Brand | ||||
| 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 | LIQUID | ||||
| RxCUI drug identifier | 1092373 | ||||
| Application Number | M010 | ||||
| Labeler Name | The Procter & Gamble Manufacturing Company | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Overdosage of Vicks PainQuil PM PAIN RELIEVER plus NIGHTTIME SLEEP-AID
Information about signs, symptoms, and laboratory findings of acute ovedosage and the general principles of overdose treatment.In case of overdose, get medical help or contact a Poison Control Center 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.Active ingredients (in each 30 mL) Acetaminophen 1000 mg Diphenhydramine HCl 50 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 take only one dose (30 mL) per day (24 hours) only use the dose cup provided only use as directed adults & children 12 yrs & over 30 mL at bedtime children under 12 yrs do not use
| adults & children 12 yrs & over | 30 mL at bedtime |
| children under 12 yrs | do not use |
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients alcohol, anhydrous citric acid, FD&C Blue No. 1, FD&C Red No. 40, flavor, polysorbate 20, propylene glycol, saccharin sodium, sodium benzoate, sodium chloride, sodium citrate, sorbitol, sucralose, water, xanthan gum
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.Use for the temporary relief of occasional minor aches and pains with accompanying sleeplessness.
Purpose
Information about the drug product’s indications for use.Purpose Pain reliever Nighttime sleep-aid
Spl product data elements
Usually a list of ingredients in a drug product.Vicks PainQuil PM PAIN RELIEVER plus NIGHTTIME SLEEP-AID Acetaminophen, Diphenhydramine HCl PROPYLENE GLYCOL ALCOHOL CITRIC ACID MONOHYDRATE POLYSORBATE 20 SACCHARIN SODIUM WATER FD&C RED NO. 40 SODIUM BENZOATE SODIUM CHLORIDE SODIUM CITRATE SORBITOL SUCRALOSE XANTHAN GUM DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE ACETAMINOPHEN ACETAMINOPHEN
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.PRINCIPAL DISPLAY PANEL - 354 ml bottle VICKS ® PainQuil ™ PM PAIN RELIEVER + NIGHTTIME SLEEP-AID Acetaminophen Diphenhydramine HCl STARTS WORKING FAST FOR RELIEF OF: ACHES | PAINS HEADACHE | SORE THROAT + OCCASSIONAL SLEEPLESSNESS MIDNIGHT CHERRY FLAVORED Alcohol 10% 12 FL OZ (354 ml) 834
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Drug Facts
TAMPER EVIDENT: DO NOT USE IF PRINTED SHRINKBAND IS BROKEN OR MISSING.
DIST. BY: PROCTER & GAMBLE, CINCINNATI, OH 45202
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 a breathing problem such as emphysema or chronic bronchitis glaucoma difficulty in urination due to enlargement of the prostate gland a sodium-restricted diet
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 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. for children under 12 years of age with any other product containing diphenhydramine, even one used on skin
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 reach of children.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? 1-877-881-5813
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 redness or swelling is present new symptoms occur sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness. 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 avoid alcoholic beverages drowsiness will occur 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.
Storage and handling
Information about safe storage and handling of the drug product.Other information each 30 mL contains: sodium 89 mg do not exceed 25°C and do not refrigerate.
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.Warnings Liver warning : This product contains acetaminophen. Severe liver damage may occur if you take more than 3 doses (30 mL each) in 24 hours, which is the maximum daily amount for this product 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 Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly. 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. for children under 12 years of age with any other product containing diphenhydramine, even one used on skin Ask a doctor before use if you have liver disease a breathing problem such as emphysema or chronic bronchitis glaucoma difficulty in urination due to enlargement of the prostate gland a sodium-restricted diet Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin taking sedatives or tranquilizers 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 redness or swelling is present new symptoms occur sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness. These could be signs of a serious condition. When using this product avoid alcoholic beverages drowsiness will occur do not drive a motor vehicle or operate machinery If pregnant or breast-feeding , ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
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