Allergy Plus Sinus Headache

Allergy Plus Sinus Headache
SPL v5
SPL
SPL Set ID 7364ffe1-26bf-4d05-94d0-ef946287def9
Route
ORAL
Published
Effective Date 2021-11-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (325 mg) Diphenhydramine (12.5 mg) Phenylephrine (5 mg)
Inactive Ingredients
Microcrystalline Cellulose Starch, Potato Croscarmellose Sodium Pyrrolidine Silicon Dioxide Stearic Acid Polyvinyl Alcohol, Unspecified Polyethylene Glycol, Unspecified Titanium Dioxide Talc Fd&c Yellow No. 5 Fd&c Blue No. 1 Fd&c Blue No. 2

Identifiers & Packaging

Pill Appearance
Imprint: S504 Shape: capsule Color: green Size: 19 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-11-11

Description

Acetaminophen 325 mg Diphenhydramine HCl 12.5 mg Phenylephrine HCl 5 mg

Purpose

Pain reliever Antihistamine Nasal decongestant


Medication Information

Purpose

Pain reliever

Antihistamine

Nasal decongestant

Description

Acetaminophen 325 mg Diphenhydramine HCl 12.5 mg Phenylephrine HCl 5 mg

Uses

• temporarily relieves these symptoms of hay fever and the common cold:

• runny nose

• sneezing

• headache

• minor aches and pains

• nasal congestion

• temporarily relieves these additional symptoms of hay

• fever:

• itching of the nose or throat

• itchy, watery eyes

Section 42229-5

READ AND KEEP CARTON FOR COMPLETE WARNINGS AND INFORMATION

TAMPER EVIDENT : DO NOT USE IF CARTON IS OPENED OR SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Section 50565-1

Keep out of reach of children.

In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Section 53414-9

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

Warnings

Liver warning: This product contains acetaminophen.

Severe liver damage may occur if you take:

• more than 4,000 mg of acetaminophen in 24 hours

• 3 or more alcoholic drinks every day while using this product

• with other drugs containing acetaminophen

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

• blisters

• rash

• skin reddening

If a skin reaction occurs, stop use and seek medical help right away.

Directions

• do not use more than directed

• adults and children 12 years and over

• take 2 caplets every 4 hours

• do not take more than 10 caplets in 24 hours

• children under 12 years: ask a doctor

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 product containing diphenhydramine, even one used on skin

• if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

• if you have ever had an allergic reaction to this product or any of its ingredients

Label and Carton

label

carton

Other Information

• store at 25oC (77oF); excursions permitted between 15o-30oC (59o-86oF)

Inactive Ingredients

microcrystalline cellulose, pregelatinized starch, croscarmellose sodium,

polyvinyl pyrrolidone, colloidal silicon dioxide, stearic acid powder, polyvinyl alcohol, polyethylene glycol, titanium dioxide, talc, tartrazine yellow lake, brilliant blue lake, indigo carmine lake

Questions Or Comments?

1-888-333-9792

When Using This Product

do not exceed recommended dosage

• excitability may occur, especially in children

• marked drowsiness may occur

• alcohol, sedatives, and tranquilizers may increase drowsiness

• use caution when driving a motor vehicle or operating machinery

• avoid alcoholic beverages

Stop Use and Ask A Doctor If

• nervousness, dizziness, or sleeplessness occur

• pain or nasal congestion gets worse or lasts more than 7 days

• new symptoms occur

• fever gets worse or lasts more than 3 days

• redness or swelling is present

Active Ingredients (in Each Caplet)

Acetaminophen 325 mg

Diphenhydramine HCl 12.5 mg

Phenylephrine HCl 5 mg

Ask A Doctor Before Use If You Have

• liver disease

• glaucoma

• thyroid disease

• heart disease

• diabetes

• high blood pressure

• difficulty in urination due to enlargement of the prostate gland

• a breathing problem such as emphysema or chronic bronchitis

Ask A Doctor Or Pharmacist Before Use If You Are

• taking the blood thinning drug warfarin

• taking sedatives or tranquilizers


Structured Label Content

Uses

• temporarily relieves these symptoms of hay fever and the common cold:

• runny nose

• sneezing

• headache

• minor aches and pains

• nasal congestion

• temporarily relieves these additional symptoms of hay

• fever:

• itching of the nose or throat

• itchy, watery eyes

Section 42229-5 (42229-5)

READ AND KEEP CARTON FOR COMPLETE WARNINGS AND INFORMATION

TAMPER EVIDENT : DO NOT USE IF CARTON IS OPENED OR SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Section 50565-1 (50565-1)

Keep out of reach of children.

In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Section 53414-9 (53414-9)

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

Purpose

Pain reliever

Antihistamine

Nasal decongestant

Warnings

Liver warning: This product contains acetaminophen.

Severe liver damage may occur if you take:

• more than 4,000 mg of acetaminophen in 24 hours

• 3 or more alcoholic drinks every day while using this product

• with other drugs containing acetaminophen

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

• blisters

• rash

• skin reddening

If a skin reaction occurs, stop use and seek medical help right away.

Directions

• do not use more than directed

• adults and children 12 years and over

• take 2 caplets every 4 hours

• do not take more than 10 caplets in 24 hours

• children under 12 years: ask a doctor

Do Not Use (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 product containing diphenhydramine, even one used on skin

• if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

• if you have ever had an allergic reaction to this product or any of its ingredients

Label and Carton (label and carton)

label

carton

Other Information (Other information)

• store at 25oC (77oF); excursions permitted between 15o-30oC (59o-86oF)

Inactive Ingredients

microcrystalline cellulose, pregelatinized starch, croscarmellose sodium,

polyvinyl pyrrolidone, colloidal silicon dioxide, stearic acid powder, polyvinyl alcohol, polyethylene glycol, titanium dioxide, talc, tartrazine yellow lake, brilliant blue lake, indigo carmine lake

Questions Or Comments? (Questions or comments?)

1-888-333-9792

When Using This Product (When using this product)

do not exceed recommended dosage

• excitability may occur, especially in children

• marked drowsiness may occur

• alcohol, sedatives, and tranquilizers may increase drowsiness

• use caution when driving a motor vehicle or operating machinery

• avoid alcoholic beverages

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

• nervousness, dizziness, or sleeplessness occur

• pain or nasal congestion gets worse or lasts more than 7 days

• new symptoms occur

• fever gets worse or lasts more than 3 days

• redness or swelling is present

Active Ingredients (in Each Caplet) (Active ingredients (in each caplet))

Acetaminophen 325 mg

Diphenhydramine HCl 12.5 mg

Phenylephrine HCl 5 mg

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

• liver disease

• glaucoma

• thyroid disease

• heart disease

• diabetes

• high blood pressure

• difficulty in urination due to enlargement of the prostate gland

• a breathing problem such as emphysema or chronic bronchitis

Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)

• taking the blood thinning drug warfarin

• taking sedatives or tranquilizers


Advanced Ingredient Data


Raw Label Data

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