Allergy Plus Sinus Headache

Allergy Plus Sinus Headache
SPL v4
SPL
SPL Set ID 772d0184-8c41-40f1-bbef-7e68692eec66
Route
ORAL
Published
Effective Date 2024-09-02
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
Starch, Corn Croscarmellose Sodium Dibasic Calcium Phosphate Dihydrate Magnesium Stearate Microcrystalline Cellulose Polyethylene Glycol, Unspecified Polyvinyl Alcohol, Unspecified Povidone Silicon Dioxide Stearic Acid Talc Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: SD18 Shape: oval Color: green Size: 19 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-09-02

Description

Drug Facts

Purpose

Pain reliever Antihistamine Nasal decongestant


Medication Information

Purpose

Pain reliever

Antihistamine

Nasal decongestant

Description

Drug Facts

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.  In case of overdose, get medical help or contact a Poison Control Center right away.1(800)222-1222

Section 53414-9

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

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
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
  • 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 
  • hives
  • facial swelling 
  • asthma (wheezing) 
  • shock

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



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 acetaminophen, ask a doctor or pharmacist.
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
Other Information
  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
Inactive Ingredients

croscarmellose sodium, colloidal silicon dioxide, dibasic calcium phosphate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, starch, talc, titanium dioxide

Questions Or Comments?

1-800-373-6981 (toll-free)

Principal Display Panel

Allergy plus

Sinus headache

Acetaminophen



Diphenhydramine HCl

Phenylephrine HCl

Pain reliever / Antihistamine /



Relieves:

runny nose • sneezing • headache

• minor aches and pains • hay fever

• nasal congestion • itching of the nose or throat

• itchy, watery eyes

Labe

Carton

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
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
Active Ingredient (in Each Liquid Filled Capsule)

Acetaminophen 325 mg

Diphenhydramine HCl 12.5 mg

Phenylephrine HCl 5 mg


Structured Label Content

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.  In case of overdose, get medical help or contact a Poison Control Center right away.1(800)222-1222

Section 53414-9 (53414-9)

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

Purpose

Pain reliever

Antihistamine

Nasal decongestant

uses (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
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
  • 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 
  • hives
  • facial swelling 
  • asthma (wheezing) 
  • shock

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



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 acetaminophen, ask a doctor or pharmacist.
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
Other Information (Other information)
  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
Inactive Ingredients (Inactive ingredients)

croscarmellose sodium, colloidal silicon dioxide, dibasic calcium phosphate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, starch, talc, titanium dioxide

Questions Or Comments? (Questions or comments?)

1-800-373-6981 (toll-free)

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Allergy plus

Sinus headache

Acetaminophen



Diphenhydramine HCl

Phenylephrine HCl

Pain reliever / Antihistamine /



Relieves:

runny nose • sneezing • headache

• minor aches and pains • hay fever

• nasal congestion • itching of the nose or throat

• itchy, watery eyes

Labe

Carton

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
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
Active Ingredient (in Each Liquid Filled Capsule) (Active ingredient (in each liquid-filled capsule))

Acetaminophen 325 mg

Diphenhydramine HCl 12.5 mg

Phenylephrine HCl 5 mg


Advanced Ingredient Data


Raw Label Data

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