Dosage and administration
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
Vicks
- Manufacturer
- The Procter & Gamble Manufacturing Company | Granules India Limited
- Effective date
- 2026-10-05
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- daily-update
- Hydrated at
- 2026-10-07 01:01:56
Label at a glance#
ProductVicks PainQuil PM PAIN RELIEVER plus NIGHTTIME SLEEP-AID
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE, ACETAMINOPHEN
Label structure12 sections
Storage and handling
each 30 mL dose contains: sodium 21 mg store at no greater than 25°C (77ºF) and do not refrigerate.
Contacts and useful links#
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drug Facts
Active ingredients (in each 30 mL)
Acetaminophen 1000 mg
Diphenhydramine HCl 50 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 (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
OTC - ASK DOCTOR SECTION
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.
OVERDOSAGE SECTION
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 (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 |
Other information
- each 30 mL dose contains: sodium 21 mg
- store at no greater than 25°C (77ºF) and do not refrigerate.
Inactive ingredients
alcohol, anhydrous citric acid, D&C Yellow No. 10, FD&C Green No. 3, FD&C Red No. 40, FD&C Yellow No. 6, flavor, glycerin, polysorbate 20, propylene glycol, saccharin sodium, sodium benzoate, sodium citrate, sorbitol, sucralose, water
Questions?
1-877-881-5813
SPL UNCLASSIFIED SECTION
TAMPER EVIDENT: DO NOT USE IF PRINTED SHRINKBAND IS BROKEN OR MISSING.
SPL UNCLASSIFIED SECTION
DIST. BY: PROCTER & GAMBLE,
CINCINNATI, OH 45202
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
HONEY FLAVORED
Alcohol 10%
12 FL OZ (354 ml)
Product Linked Resources#
DailyMed Product Concepts#
Products#
Every source-derived product name is available through these pages.
- Vicks PainQuil PM PAIN RELIEVER plus NIGHTTIME SLEEP-AID
- Acetaminophen, Diphenhydramine HCl
- DIPHENHYDRAMINE HYDROCHLORIDE
- DIPHENHYDRAMINE
- ACETAMINOPHEN
- PROPYLENE GLYCOL
- ALCOHOL
- POLYSORBATE 20
- ANHYDROUS CITRIC ACID
- WATER
- SACCHARIN SODIUM
- TRISODIUM CITRATE DIHYDRATE
- FD&C RED NO. 40
- FD&C GREEN NO. 3
- D&C YELLOW NO. 10
- FD&C YELLOW NO. 6
- GLYCERIN
- SODIUM BENZOATE
- SORBITOL
- SUCRALOSE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 84126-350 | 84126-350-12 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
Older Hydrated Versions#
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 1 | 2025-04-14 | full-release | 2026-06-01 01:00:25 |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Vicks PainQuil and Vicks PainQuil PM PAIN RELIEVER | ACETAMINOPHEN, DIPHENHYDRAMINE HCL | The Procter & Gamble Manufacturing Company | 334f3194-9737-8f85-e063-6394a90ad416 | 2025-04-24 | Warnings | 84126-350-12 84126035012 |
| Vicks PainQuil PM PAIN RELIEVER plus NIGHTTIME SLEEP-AID | ACETAMINOPHEN, DIPHENHYDRAMINE HCL | The Procter & Gamble Manufacturing Company | 32bedbbc-b939-1bea-e063-6394a90a6934 | 2025-04-14 | Warnings | 84126-350-12 84126-350 84126035012 32bedbbc-b939-1bea-e063-6394a90a6934 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.