1126 - GNP - 2019-1001
Drug Labeling and Warnings
Drug Details [pdf]
ALLERGY PLUS SEVERE SINUS HEADACHE- acetaminophen, diphenhydramine hydrochloride, and phenylephrine hydrochloride tablet, coated
AmeriSource Bergen
Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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1126 - GNP - 2019-1001
Uses
- temporarily relieves these symptoms of hay fever or other upper respiratory allergies:
- runny nose
- sneezing
- headache
- minor aches and pains
- nasal congestion
- sinus congestion and pressure
- itchy, watery eyes
- itching of the nose or throat
Warnings
Liver warning
This product contains acetaminophen. Severe liver damage may occur if you take
- more than 12 caplets in 24 hours, which is the maximum daily amount
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day while using this product
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
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- glaucoma
- trouble urinating due to an enlarged 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 drinks
- be careful when driving a motor vehicle or operating machinery
Stop use and ask a doctor if
- nervousness, dizziness, or sleeplessness occur
- redness or swelling is present
- pain or nasal congestion gets worse or lasts more than 7 days
- new symptoms occur
- fever gets worse or lasts more than 3 days
These could be signs of a serious condition.
Overdose warning
Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Directions
- do not take more than directed (see overdose warning)
| adults and children 12 years and over |
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| children under 12 years |
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Other information
- store between 20°-25°C (68°-77°F) in a dry place
- retain carton for complete product information
Inactive ingredients
colloidal silicon dioxide, copovidone, croscarmellose sodium, FD&C blue #1, hypromellose, lactose anhydrous, magnesium stearate, methylparaben, povidone, pregelatinized starch, propylene glycol, propylparaben, sodium starch glycolate, stearic acid, titanium dioxide, triacetin
PRINCIPAL DISPLAY PANEL
Good Neighbor Pharmacy®
Compare to Benadryl® Severe Allergy Plus Sinus Headache active ingredients†
NDC: 46122-053-60
See New Warnings Information
Maximum Strength
Allergy Plus Severe Sinus Headache
pain reliever, nasal decongestant, antihistamine
acetaminophen, phenylephrine hcl, diphenhydramine hcl
Relieves:
Sinus Headache
Sinus Pressure
Sinus Congestion
Sneezing & Itchy, Watery Eyes
Runny Nose
Itchy Throat
20 caplets
| ALLERGY PLUS SEVERE SINUS HEADACHE
acetaminophen, diphenhydramine hydrochloride, and phenylephrine hydrochloride tablet, coated |
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| Labeler - AmeriSource Bergen (007914906) |