FDA Label for Vicks Painquil Pm Pain Reliever Plus Nighttime Sleep-aid
View Indications, Usage & Precautions
- OTHER
- ACTIVE INGREDIENTS (IN EACH 30 ML)
- PURPOSE
- USES
- WARNINGS
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
- STOP USE AND ASK A DOCTOR IF
- WHEN USING THIS PRODUCT
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- OVERDOSAGE
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS?
- PRINCIPAL DISPLAY PANEL - CONVENIENCE PACK
Vicks Painquil Pm Pain Reliever Plus Nighttime Sleep-aid Product Label
The following document was submitted to the FDA by the labeler of this product The Procter & Gamble Manufacturing Company. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Other
Vicks ® PainQuil™ PM PAIN RELIEVER + NIGHTTIME SLEEP-AID
Drug Facts
TAMPER EVIDENT: DO NOT USE IF PRINTED SHRINKBAND IS BROKEN OR MISSING.
DIST. BY: PROCTER & GAMBLE,
CINCINNATI, OH 45202
Vicks ® PainQuil™ PAIN RELIEVER
Drug Facts
TAMPER EVIDENT: DO NOT USE IF PRINTED SHRINKBAND IS BROKEN OR MISSING.
DIST. BY: PROCTER & GAMBLE,
CINCINNATI, OH 45202
Active Ingredients (In Each 30 Ml)
Acetaminophen 1000 mg
Diphenhydramine HCl 50 mg
Acetaminophen 1000 mg
Purpose
Pain reliever
Nighttime sleep-aid
Pain reliever
Uses
- for the temporary relief of occasional minor aches and pains with accompanying sleeplessness.
- sore throat
- headache
- muscular aches
- backache
for the temporary relief of minor aches and pains associated with:
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
- 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.
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
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
- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
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
- liver disease
- a sodium-restricted diet
Ask A Doctor Or Pharmacist Before Use If You Are
- taking the blood thinning drug warfarin
- taking sedatives or tranquilizers
- taking the blood thinning drug warfarin
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.
- 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.
Insomnia may be a symptom of serious underlying medical illness.
These could be signs of a serious condition.
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
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding,ask a health professional before use.
If pregnant or breast-feeding,ask a health professional before use.
Otc - Keep Out Of Reach Of Children
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.
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
- take only as directed
- do not exceed 3 doses (30 mL each) per day (24 hours)
- only use the dose cup provided
adults & children 12 yrs & over | 30 mL at bedtime |
children under 12 yrs | do not use |
adults & children 12 yrs & over | 30 mL every 6 hours |
children under 12 yrs | do not use |
Other Information
- each 30 mL contains: sodium 89 mg
- do not exceed 25°C and do not refrigerate.
- each 30 mL contains: sodium 93 mg
- do not exceed 25°C and do not refrigerate.
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
alcohol, anhydrous citric acid, FD&C Red No. 40, flavor, polysorbate 20, propylene glycol, saccharin sodium, sodium benzoate, sodium chloride, sodium citrate, sorbitol, sucralose, water, xanthan gum
Questions?
1-877-881-5813
1-877-881-5813
Principal Display Panel - Convenience Pack
Vicks
®PainQuil™ PAIN RELIEVER / Vicks
®PainQuil™ PM PAIN RELIEVER + NIGHTTIME SLEEP-AID
MAX STRENGTH‡
VALUE PACK
‡Maximum strength dose of active ingredients per dosing interval, only use as directed.
Vicks ®PainQuil™ PAIN RELIEVER
STARTS WORKING FAST FOR RELIEF OF:
ACHES
PAINS
HEADACHE
SORE THROAT
BLACK CHERRY FLAVORED
Alcohol 10%
Vicks ®PainQuil™ PM PAIN RELIEVER + NIGHTTIME SLEEP-AID
STARTS WORKING FAST FOR RELIEF OF:
ACHES
PAINS
HEADACHE
SORE THROAT
+
OCCASSIONAL SLEEPLESSNESS
MIDNIGHT CHERRY FLAVORED
Alcohol 10%
2 BOTTLES - 1 PAINQUIL/1 PAINQUIL PM 12 FL OZ (354 mL) EACH; TOTAL 24 FL OZ (708 mL)
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