Other
Drug Facts
TAMPER EVIDENT: DO NOT USE IF PRINTED SEAL UNDER CAP IS MISSING OR DAMAGED.
‡Maximum strength dose of active ingredients per dosing interval, only use as directed.
DIST. BY PROCTER & GAMBLE,
CINCINNATI, OH 45202
Vicks Painquil Pm Capsule, Liquid Filled
FDA Label NDC 84126-375
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by The Procter & Gamble Manufacturing Company for the product Vicks Painquil Pm (NDC 84126-375). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, active ingredients (in each liquicap), purpose, use, warnings, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredients (In Each Liquicap)
Acetaminophen 500 mg
Diphenhydramine HCl 25 mg
Purpose
Pain reliever
Nighttime sleep-aid
Use
- for the temporary relief of occasional minor aches and pains with accompanying sleeplessness.
Warnings
Liver warning:
This product contains acetaminophen. Severe liver damage may occur if you take
- more than 3 doses (2 LiquiCaps 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
- skin reddening
- blisters
- rash
Allergy Alert:
Acetaminophen may cause severe skin reactions. Symptoms may include:
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
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 or cough 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.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Overdosage
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.
Directions
- take only one dose (2 LiquiCaps) per day (24 hours)
| adults & children 12 yrs & over | 2 LiquiCaps at bedtime |
| children under 12 yrs | do not use |
Other Information
store at no greater than 25°C (77°F)
Inactive Ingredients
1,4 sorbitan, D&C Red No. 33, FD&C Blue No. 1, gelatin, glycerin, mannitol, polyethylene glycol 400, polyethylene glycol 600, polyvinyl acetate phthalate, povidone, propylene glycol, sorbitol, titanium dioxide, water
Questions?
1-877-881-5813
Principal Display Panel - 100 Liquicaps™
MAX STRENGTH‡
VICKS®
PainQuil™ PM
LIQUICAPS™
PAIN RELIEVER
+ NIGHTTIME SLEEP-AID
Acetaminophen, Diphenhydramine HCl
STARTS WORKING FAST
FOR RELIEF OF:
ACHES | PAINS | HEADACHE | SORE THROAT |
+ OCCASSIONAL SLEEPLESSNESS
100 LIQUICAPS™
375 (375)
* Please review the disclaimer below.
