Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 1808ba46-e5ce-40d2-b62f-6a88de8aabf5
Route
ORAL
Published
Effective Date 2010-08-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (650 mg) Diphenhydramine (25 mg) Phenylephrine (10 mg)
Inactive Ingredients
Hypromellose Magnesium Silicate Magnesium Stearate Cellulose, Microcrystalline Titanium Dioxide Croscarmellose Sodium Stearic Acid

Identifiers & Packaging

Pill Appearance
Imprint: RC;CPE Shape: oval Color: white Size: 17 mm Score: 2
Marketing Status
OTC MONOGRAPH FINAL Active Since 2010-04-05

Description

Acetaminophen 650 mg Diphenhydramine Hydochloride 25 mg Phenylephrine Hydrochloride 10 mg


Medication Information

Warnings and Precautions

LIVER WARNING : THIS PRODUCT CONTAINS ACETAMINOPHEN.SEVERE LIVER

DAMAGE MAY OCCUR IF ADULT TAKES MORE THAN 6 DOSES IN 24 HOURS

WHICH IS THE MAXIMUM DAILY AMOUNT, A CHILD TAKES MORE THAN 5 DOSES

IN 24 HOURS , WHICH IS THE MAXIMUM DAILY AMOUNT , TAKEN WITH OTHER

DRUGS CONTAINING ACETAMINOPHEN ,ADULT HAS 3 OR MORE ALCOHOLIC DRINKS

EVERYDAY WHILE USING THIS PRODUCT



Indications and Usage

Temporarily relieves symptoms associated with the common cold, flu, hay fever

and other respiratory allergies

nasal and sinus congestion

itching of the nose or throat

minor aches and pains

sneezing and runny nose

itchy, watery eyes

headaches

Dosage and Administration

Directions



adults and children 12 years of age and older: take 1 caplet every 4 hours as needed.

Do not exceed 6 doses In a 24 hour period or as directed by a doctor



children 6 to under 12 years of age: take 1/2 caplet every 4 hours as needed.

Do not exceed 5 doses In a 24 hour period or as directed by a doctor



children under 6 years of ago: consult a doctor

Description

Acetaminophen 650 mg Diphenhydramine Hydochloride 25 mg Phenylephrine Hydrochloride 10 mg

Section 34088-5

In case of overdose, get medical help or contact a Poison Control Center immediately. Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.

Section 42229-5

Other Information



_ store at 15'-30'C (59'-86'F)

Section 50565-1
KEEP OUT OF REACH OF CHILDREN

Section 50566-9
Stop use and ask a doctor if

- nervousness, dizziness or sleeplessness occur,

- pain symptoms do not improve after 7 days for adults or 5 days for children orlend to recur

_ cough and cold symptoms do not improve within 7 days or recur

_ symptoms are accompanied by fever that lasts more than 3 days

_ sore throat is severe or persists for more than 2 days

_ new symptoms occur or redness, swelling, rash, persistent headache, nausea or vomiting occur.

These could be signs of a serious condition
Section 50567-7

When using this product



marked drowsiness may occur _ excitability may occur, especially in children



alcohol, sedatives and tranquilizers may increase the drowsiness effect _ avoid alcoholic drinks _ use caution when driving a motor vehicle or operating machinery

Section 50568-5

Ask a doctor or pharmacist before use if the user is taking the blood thinning drug "Warfarin"

Section 50569-3

Ask a doctor before use if the user has liver damage persistent or chronic cough, such as occurs with smoking, asthma, chronic bronchitis, or emphysema,  cough is accompanied by excessive phlegm (mucus),  high blood pressure,  thyroid disease,  glaucoma,  diabetes,  heart disease,  a breathing problem such as emphysema or chronic bronchitis, difficulty In urination due to enlargement of the prostate gland

Section 50570-1

Do not use _ with any other drug containing acetaminophen (prescription or nonpreescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist _ more than directed _ if you are taking sedatives or tranquilizers without first consulting your doctor _ if you are taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's Disease) or for two weeks after stopping the MAD I drug if are uncertain whether your prescription drug contains an MAOI, consuit a health professional before taking this product

Section 51727-6
croscarmellose sodium,htpromellose,magnesium silicate,magnesium stearate,



microcrystalline cellulose,polyvinylpyrrolidone,silica,sodium starch glycolate,starch,



stearic acid,titanium dioxide.
Section 51945-4
 
Section 53414-9

If pregnant or breast feeding, ask a health professional before use.

Section 55105-1

Pain Reliever/Fever Reducer



Antihistamine/Cough Suppressant



Nasal Decongestant

Section 55106-9

Acetaminophen 650 mg

Diphenhydramine Hydochloride 25 mg

Phenylephrine Hydrochloride 10 mg


Structured Label Content

Indications and Usage (34067-9)

Temporarily relieves symptoms associated with the common cold, flu, hay fever

and other respiratory allergies

nasal and sinus congestion

itching of the nose or throat

minor aches and pains

sneezing and runny nose

itchy, watery eyes

headaches

Dosage and Administration (34068-7)

Directions



adults and children 12 years of age and older: take 1 caplet every 4 hours as needed.

Do not exceed 6 doses In a 24 hour period or as directed by a doctor



children 6 to under 12 years of age: take 1/2 caplet every 4 hours as needed.

Do not exceed 5 doses In a 24 hour period or as directed by a doctor



children under 6 years of ago: consult a doctor

Warnings and Precautions (34071-1)

LIVER WARNING : THIS PRODUCT CONTAINS ACETAMINOPHEN.SEVERE LIVER

DAMAGE MAY OCCUR IF ADULT TAKES MORE THAN 6 DOSES IN 24 HOURS

WHICH IS THE MAXIMUM DAILY AMOUNT, A CHILD TAKES MORE THAN 5 DOSES

IN 24 HOURS , WHICH IS THE MAXIMUM DAILY AMOUNT , TAKEN WITH OTHER

DRUGS CONTAINING ACETAMINOPHEN ,ADULT HAS 3 OR MORE ALCOHOLIC DRINKS

EVERYDAY WHILE USING THIS PRODUCT



Section 34088-5 (34088-5)

In case of overdose, get medical help or contact a Poison Control Center immediately. Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.

Section 42229-5 (42229-5)

Other Information



_ store at 15'-30'C (59'-86'F)

Section 50565-1 (50565-1)
KEEP OUT OF REACH OF CHILDREN

Section 50566-9 (50566-9)
Stop use and ask a doctor if

- nervousness, dizziness or sleeplessness occur,

- pain symptoms do not improve after 7 days for adults or 5 days for children orlend to recur

_ cough and cold symptoms do not improve within 7 days or recur

_ symptoms are accompanied by fever that lasts more than 3 days

_ sore throat is severe or persists for more than 2 days

_ new symptoms occur or redness, swelling, rash, persistent headache, nausea or vomiting occur.

These could be signs of a serious condition
Section 50567-7 (50567-7)

When using this product



marked drowsiness may occur _ excitability may occur, especially in children



alcohol, sedatives and tranquilizers may increase the drowsiness effect _ avoid alcoholic drinks _ use caution when driving a motor vehicle or operating machinery

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if the user is taking the blood thinning drug "Warfarin"

Section 50569-3 (50569-3)

Ask a doctor before use if the user has liver damage persistent or chronic cough, such as occurs with smoking, asthma, chronic bronchitis, or emphysema,  cough is accompanied by excessive phlegm (mucus),  high blood pressure,  thyroid disease,  glaucoma,  diabetes,  heart disease,  a breathing problem such as emphysema or chronic bronchitis, difficulty In urination due to enlargement of the prostate gland

Section 50570-1 (50570-1)

Do not use _ with any other drug containing acetaminophen (prescription or nonpreescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist _ more than directed _ if you are taking sedatives or tranquilizers without first consulting your doctor _ if you are taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's Disease) or for two weeks after stopping the MAD I drug if are uncertain whether your prescription drug contains an MAOI, consuit a health professional before taking this product

Section 51727-6 (51727-6)
croscarmellose sodium,htpromellose,magnesium silicate,magnesium stearate,



microcrystalline cellulose,polyvinylpyrrolidone,silica,sodium starch glycolate,starch,



stearic acid,titanium dioxide.
Section 51945-4 (51945-4)
 
Section 53414-9 (53414-9)

If pregnant or breast feeding, ask a health professional before use.

Section 55105-1 (55105-1)

Pain Reliever/Fever Reducer



Antihistamine/Cough Suppressant



Nasal Decongestant

Section 55106-9 (55106-9)

Acetaminophen 650 mg

Diphenhydramine Hydochloride 25 mg

Phenylephrine Hydrochloride 10 mg


Advanced Ingredient Data


Raw Label Data

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