Allergy plus Sinus Headache
- Dosage form
- TABLET, FILM COATED
- Labeler
- Shield Pharmaceuticals Corp
- Label updated
- 2025-10-31
- Retrieved
- 2026-09-07
- Active ingredients
- ACETAMINOPHEN · DIPHENHYDRAMINE HYDROCHLORIDE
Label information
Drug Facts
Active ingredient (in each liquid-filled capsule)
Acetaminophen 325 mg
Diphenhydramine HCl 12.5 mg
Phenylephrine HCl 5 mg
Purpose
Pain reliever
Antihistamine
Nasal decongestant
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.
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
- 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
Label information
If pregnant or breast-feeding, ask a health professional before use.
Label information
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
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)
Label information
TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.
Inactive ingredients
corn starch, croscarmellose sodium, crospovidone, D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, FD&C red #40 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, stearic acid, talc, titanium dioxide
Questions or comments?
1-800-373-6981 (toll-free)
Label information
Shield Pharmaceuticals Corp.
Hauppauge, NY 11788
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
[Image in the official label — see DailyMed source]
Carton
[Image in the official label — see DailyMed source]
DailyMed Set ID: ea74e6a0-ff0f-44dc-8fdc-54c4a860c1a8 · Version 4
NDC: 83059-0045