FDA Label for Nighttime Relief, Cold And Flu, 24-7 Life By 7-eleven
View Indications, Usage & Precautions
- DRUG FACTS
- ACTIVE INGREDIENTS
- PURPOSE
- USES
- WARNINGS
- LIVER WARNING
- ALLERGY ALERT
- SORE THROAT WARNING
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF
- 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
- NIGHTTIME RELIEF, COLD & FLU, 24/7 LIFE BY 7-ELEVEN TM - PDP/BOTTLE LABEL
Nighttime Relief, Cold And Flu, 24-7 Life By 7-eleven 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 30 mL)
Acetaminophen 650 mg
Dextromethorphan HBr 30 mg
Doxylamine succinate 12.5 mg
Purpose
Purpose
Pain reliever/fever reducer
Cough suppressant
Antihistamine
Uses
Uses
- temporarily relieves common cold and flu symptoms:
- runny nose and sneezing
- cough due to minor throat and bronchial irritation
- minor aches and pains
- sore throat
- headache
- temporarily reduces fever
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
- 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.
Sore Throat Warning
Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.
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
- if you have ever had an allergic reaction to this product or any of its ingredients
contains an MAOI, ask a doctor or pharmacist before taking this product.
Ask A Doctor Before Use If
Ask a doctor before use if you have
- difficulty in urination due to enlargement of the prostate gland
- cough that occurs with too much phlegm (mucus)
- a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema
- liver disease
- glaucoma
Ask A Doctor Or Pharmacist Before Use If
Ask a doctor or pharmacist before use if you are
- taking the blood thinning drug warfarin
- taking sedatives or tranquilizers
When Using This Product
When using this product
- excitability may occur, especially in children
- avoid alcoholic beverages
- marked drowsiness may occur
- alcohol, sedatives, and tranquilizers may increase drowsiness
- use caution when driving a motor vehicle or operating machinery
Stop Use And Ask A Doctor If
Stop use and ask a doctor if
- pain or cough 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
- cough comes back or occurs with rash or headache that lasts.
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
- do not exceed 4 doses per 24 hours
- mL = milliliter
- only use the dose cup provided
- adults and children 12 years and over: 30 mL every 6 hours
- children under 12 years: do not use
Other Information
Other information
- each 30 mL contains: sodium 22 mg
- store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
- use by expiration date on package
Inactive Ingredients
Inactive ingredients
anhydrous citric acid, D&C yellow #10, FD&C green #3, FD&C yellow #6, flavors, glycerin, high fructose corn syrup, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium chloride, sodium citrate dihydrate, sodium saccharin, sucralose
Questions Or Comments
Questions or comments?1-877-507-6516
Nighttime Relief, Cold & Flu, 24/7 Life By 7-Eleven Tm - Pdp/Bottle Label
[24/7 Life by 7-ElevenTM logo]
For Ages 12 Years & Over
Cold&Flu
Nighttime Relief
Acetaminophen / Pain Reliever/Fever Reducer
Dextromethorphan HBr / Cough Suppressant
Doxylamine Succinate / Antihistamine
Relieves: Minor Aches & Pains, Sore Throat,
Fever, Headache, Runny Nose, Sneezing, Cough
6 FL OZ
(177 mL)
[eucalyptus leaves image]
Eucalyptus
Mint Flavor
compare to Vicks
®
NyQuil
® Cold & Flu
active ingredients*
* Please review the disclaimer below.