Allergy Plus Sinus Headache
7364ffe1-26bf-4d05-94d0-ef946287def9
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
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
All Sections (JSON)
Additional Information
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Source: dailymed · Ingested: 2026-02-15T12:04:40.887113 · Updated: 2026-03-14T23:05:35.877028