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  5. Label Information: Allergy Plus Sinus Headache

FDA Label for Allergy Plus Sinus Headache

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENTS (IN EACH CAPLET)
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. DO NOT USE
    6. ASK A DOCTOR BEFORE USE IF YOU HAVE
    7. ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
    8. WHEN USING THIS PRODUCT
    9. STOP USE AND ASK A DOCTOR IF
    10. OTC - PREGNANCY OR BREAST FEEDING
    11. OTC - KEEP OUT OF REACH OF CHILDREN
    12. DIRECTIONS
    13. OTHER INFORMATION
    14. INACTIVE INGREDIENTS
    15. QUESTIONS OR COMMENTS?
    16. OTHER
    17. LABEL AND CARTON

Allergy Plus Sinus Headache Product Label

The following document was submitted to the FDA by the labeler of this product Spirit Pharmaceuticals Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredients (In Each Caplet)



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
• 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.


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


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


Otc - Pregnancy Or Breast Feeding



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


Otc - Keep Out Of Reach Of Children



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.


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



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


Other



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

Distributed By:
Spirit Pharmaceuticals, LLC
Ronkonkoma, NY 11779

ORIG 05/21

Made in India


Label And Carton



label

Label - Label

Label - Label

carton


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