Allergy and Sinus Headache

Allergy and Sinus Headache is an FDA-registered drug product whose active ingredient is ACETAMINOPHEN, DIPHENHYDRAMINE HCL AND PHENYLEPHRINE HCL. It is labelled by ARMY AND AIR FORCE EXCHANGE SERVICE taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 55301-464, application M012, label effective 20260625. It is one of 2 FDA drug label records sharing the active ingredient ACETAMINOPHEN, DIPHENHYDRAMINE HCL AND PHENYLEPHRINE HCL. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing ACETAMINOPHEN, DIPHENHYDRAMINE HCL AND PHENYLEPHRINE HCL are most often described in connection with: temporarily relieves, symptoms hay, common cold, runny nose, sneezing headache, minor aches, pains nasal, fever itching. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

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

Directions do not take 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

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 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. 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 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 avoid alcoholic beverages use caution when driving a motor vehicle or operating machinery Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur pain or nasal congestion gets worse or lasts more than 7 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

FDA lists 2 drug label records with ACETAMINOPHEN, DIPHENHYDRAMINE HCL AND PHENYLEPHRINE HCL as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

What is Allergy and Sinus Headache used for?
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

Who makes Allergy and Sinus Headache?
ARMY AND AIR FORCE EXCHANGE SERVICE is the labeler of record for Allergy and Sinus Headache. 2 FDA label records share the active ingredient ACETAMINOPHEN, DIPHENHYDRAMINE HCL AND PHENYLEPHRINE HCL, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does Allergy and Sinus Headache come in?
administered by oral. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is Allergy and Sinus Headache prescription or over-the-counter?
The FDA label for this product is recorded as human otc drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Are there other products containing ACETAMINOPHEN, DIPHENHYDRAMINE HCL AND PHENYLEPHRINE HCL?
Yes. 2 FDA drug label records list ACETAMINOPHEN, DIPHENHYDRAMINE HCL AND PHENYLEPHRINE HCL as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has Allergy and Sinus Headache been recalled?
No FDA recall record in our database matches this product name or manufacturer. Recall data is updated periodically, so a very recent notice may not appear here yet.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.