Vicks Painquil And Vicks Painquil Pm Kit
FDA Label NDC 84126-377

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 And Vicks Painquil Pm (NDC 84126-377). 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 ingredient (in each liquicap), purpose, uses, 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

→ Other

→ Active Ingredient (in Each Liquicap)

→ 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

→ If Pregnant Or Breast-feeding,

→ Overdosage

→ Directions

→ Other Information

→ Inactive Ingredients

→ Questions?

→ Active Ingredients (in Each Liquicap)

→ When Using This Product

→ Principal Display Panel

Other

PainQuil Pain Reliever

Drug Facts

TAMPER EVIDENT: DO NOT USE IF PRINTED SEAL UNDER CAP IS MISSING OR DAMAGED.

DIST. BY PROCTER & GAMBLE,

CINCINNATI OH 45202

PainQuil PM Liquicaps Pain Reliever + Nighttime Sleep-Aid

Drug Facts

TAMPER EVIDENT: DO NOT USE IF PRINTED SEAL UNDER CAP IS MISSING OR DAMAGED.

DIST. BY PROCTER & GAMBLE,

CINCINNATI OH 45202

Active Ingredient (In Each Liquicap)

Acetaminophen500 mg

Purpose

Pain reliever

Nighttime sleep-aid

Uses

for the temporary relief of minor aches and pains associated with:

• sore throat • headache • muscular aches • backache

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 mor 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

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

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.

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

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 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

These could be signs of a serious condition.

• 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.

If Pregnant Or Breast-Feeding,

ask a health professional before use.

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 as directed

• do not exceed 3 doses (2 LiquiCaps each) per day (24 hours)

adults & children 12 yrs & over	2 LiquiCaps every 6 hours
children under 12 yrs	ask a doctor

• 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, ferric oxide, gelatin, glycerin, mannitol, polyethylene glycol 400, polyethylene glycol 600, polyvinyl acetate phthalate, povidone, propylene glycol, sorbitol, titanium dioxide, water

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

Active Ingredients (In Each Liquicap)

Acetaminophen 500 mg

Diphenhydramine HCl 25 mg

When Using This Product

avoid alcoholic beverages
drowsiness will occur
do not drive a motor vehicle or operate machinery

Principal Display Panel

MAX STRENGTH

VALUE PACK

VICKS®

PainQuil™

LIQUICAPS _™

Vicks PainQuil LIQUICAPS PAIN RELIEVER

Acetaminophen

STARTS WORKING FAST

FOR RELIEF OF

ACHES | PAINS | HEADACHE | SORE THROAT

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 PAINQUIL LIQUICAPS™ 100 PAINQUIL PM LIQUICAPS™ 200 TOTAL LIQUICAPS™

377 (377)

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