FDA Label for Allergy Sinus, Lil Drug Store
View Indications, Usage & Precautions
- DRUG FACTS
- ACTIVE INGREDIENTS
- PURPOSE
- USES
- WARNINGS
- LIVER WARNING
- ALLERGY ALERT
- DO NOT USE
- ASK A DOCTOR
- ASK A DOCTOR BEFORE USE IF YOU ARE
- WHEN USING THIS PRODUCT
- STOP USE AND ASK A DOCTOR IF
- IF PREGNANT OR BREAST-FEEDING
- KEEP OUT OF REACH OF CHILDREN
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- ALLERGY SINUS, LIL' DRUG STORE ® - PDP/PACKAGE
Allergy Sinus, Lil Drug Store Product Label
The following document was submitted to the FDA by the labeler of this product Lil' Drug Store Products, Inc.. 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.
Drug Facts
Drug Facts
Active Ingredients
Active ingredients (in each tablet)
Acetamionophen 325 mg
Chlorpheniramine maleate 2 mg
Phenylephrine Hydrochloride 5 mg
Purpose
Purpose
Pain reliever
Antihistamine
Nasal decongestant
Uses
Uses
- temporarily relieves these symptoms of hay fever or other upper respiratory allergies:
- headache
- sinus congestion and pressure
- nasal congestion
- runny nose and sneezing
- minor aches and pains
- temporarily relieves these additional symptoms of hay fever:
- itching of the nose or throat
- itchy, watery eyes
- helps clear nasal passages
- helps decongest sinus openings and passages
Warnings
Warnings
Liver Warning
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
- more than 4,000 mg of acetaminophen 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.
Allergy Alert
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
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.
- 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
Ask a doctor before use if you have
- liver disease
- heart disease
- glaucoma
- diabetes
- thyroid disease
- high blood pressure
- trouble urinating due to an enlarged prostate gland
- a breathing problem such as emphysema or chronic bronchitis
Ask A Doctor Before Use If You Are
Ask a doctor before use if you are
- taking sedatives or tranquilizers.
- taking the blood thinning drug warfarin.
When Using This Product
When using this product
- do not exceed recommended dosage
- excitability may occur, especially in children
- 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
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 These could be signs of a serious condition.
If Pregnant Or Breast-Feeding
If pregnant or breast-feeding, ask a health professional before use.
Keep Out Of Reach Of Children
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.
Directions
Directions
- do not take more than directed
- take 2 tablets every 4 to 6 hours as needed
- do not take more than 12 tablets in 24 hours or as directed by a doctor
- ask a doctor
adults and children 12 years and over | |
children under 12 years of age |
Other Information
Other information
- store at room temperature 59-86°F (15-30°C)
- avoid excessive heat and humidity
Inactive Ingredients
Inactive ingredients
corn starch, crospovidone, hypromellose, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, stearic acid
Questions Or Comments?
Questions or comments?
call toll-free
1-877-507-6516 (M-F 8AM-4:30PM CST)
Allergy Sinus, Lil' Drug Store ® - Pdp/Package
[caduceus]
on
the
Go
PACKS
Allergy
Sinus [tablets image]
Allergy Sinus
Acetaminophen, Chlorpheniramine maleate, Phenylephrine hydrochloride
Pain Reliever, Antihistamine, Nasal Decongestant
Relief of
- Sinus Congestion & Pressure
- Nasal Congestion
- Runny Nose & Sneezing
6
Tablets
3POUHES, 2 TABLETS PER POUCH
[Lil' Drug Store logo]
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