FDA Label for Acetaminophen Dextromethorphan Hydrobromide Doxylamine Succinate Phenylephrine Hydrochloride
View Indications, Usage & Precautions
- ACTIVE INGREDIENT
- PURPOSE
- USES
- LIVER WARNING
- ALLERGY ALERT WARNING
- SORE THROAT WARNING
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
- WHEN USING THIS PRODUCT
- STOP USE AND ASK A DOCTOR IF
- IF PREGNANT OR BREAST-FEEDING
- KEEP OUT OF THE REACH OF CHILDREN
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- NIGHTTIME SOFTGELS
Acetaminophen Dextromethorphan Hydrobromide Doxylamine Succinate Phenylephrine Hydrochloride Product Label
The following document was submitted to the FDA by the labeler of this product Granules India Limited. 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 Ingredient
Acetaminophen 325 mg
Dextromethorphan hydrobromide 10 mg
Doxylamine succinate 6.25 mg
Phenylephrine hydrochloride 5 mg
Purpose
Pain reliever/fever reducer
Cough suppressant
Antihistamine
Nasal decongestant
Uses
• temporarily relieves these symptoms due to cold and flu:
sneezing
itching of the nose, throat or watery eyes due to hay fever
cough
nasal congestion
sinus congestion and pressure
sore throat
headache
minor aches and pains
runny nose
• helps clear nasal passages and shrinks swollen membranes
• temporarily reduces fever
Liver Warning
This product contains acetaminophen. Severe liver damage may occur if you take
• more than 10 softgels in 24 hours, which is the maximum daily amount for this product
• with other drugs containing acetaminophen
• 3 or more alcoholic drinks every day while using this product
Allergy Alert Warning
acetaminophen may cause severe skin or severe allergic reactions. Symptoms may
include:
• skin reddening
• blisters
• rash
• hives
• facial swelling
• asthma (wheezing)
• shock
If a skin or allergic reaction occurs, stop use and seek medical help right away.
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
• 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.
• if you ever had an allergic reaction to this product or any of its ingredients.
• in children 12 years of age.
Ask A Doctor Before Use If You Have
• liver disease
• heart disease
• high blood pressure
• thyroid disease
• diabetes
• glaucoma
• cough with excess phlegm (mucus)
• a breathing problem such as emphysema or chronic bronchitis
• difficulty in urination due to enlargement of the prostate gland
• persistent or chronic cough occurs with smoking, asthma, or emphysema
Ask A Doctor Or Pharmacist Before Use If You Are
• taking sedatives or tranquilizers
• taking a blood thinning drug warfarin
When Using This Product
• do not exceed recommended dose
• may cause marked drowsiness
• avoid alcoholic beverages
• alcohol, sedatives, and tranquilizers may increase drowsiness
• be careful when driving motor vehicles or operating machinery
• may cause excitability in children
Stop Use And Ask A Doctor If
• pain, cough, 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
• cough comes back or occurs with rash or head ache that lasts for 1 week, these could be the signs of serious condition
• nervousness, dizziness, or sleeplessness occurs
If Pregnant Or Breast-Feeding
ask a health professional before use.
Keep Out Of The Reach Of Children
In case of overdose, get medical help or contact Poison Control Center right away. 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 the recommended dose
adults & children under 12 years and over
- take 2 softgels with water every 4 hours.
- do not exceed 10 softgels in 24 hours or as directed by a doctor
children under 12 years
- do not use
Other Information
• store in a cool and dry place.
• protect from sunlight.
• Parents: Learn about teen medicine abuse, WWW.StopMedicineAbuse.org
Inactive Ingredients
FD&C blue 1, FD&C yellow 10, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sodium hydroxide, sorbitol sorbitan, titanium dioxide.
Questions Or Comments?
call 1-877-770-3183 Mon-Fri 9:00 AM to 4:30 PM EST
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