NDC | 62207-913-70 |
Set ID | 50c3a7ee-04d4-363b-e054-00144ff88e88 |
Category | HUMAN OTC DRUG LABEL |
Packager | Granules India Limited |
Generic Name | |
Product Class | alpha-1 Adrenergic Agonist, Antihistamine |
Product Number | |
Application Number | PART341 |
- Active ingredient
Acetaminophen 325 mg
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Dextromethorphan hydrobromide 10 mg
Doxylamine succinate 6.25 mg
Phenylephrine hydrochloride 5 mg - Purpose
- Uses
• temporarily relieves these symptoms due to cold and flu:
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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 - Warnings
- Liver warning
This product contains acetaminophen. Severe liver damage may occur if you take
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• 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
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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.
Close - Do not use to sedate children.
- 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.
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• 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
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• 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
- When using this product
• do not exceed recommended dose
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• 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
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• 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
- 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.
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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
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• store in a cool and dry place.
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• 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.
Close - Questions or comments?
- Nighttime softgels
- INGREDIENTS AND APPEARANCE
ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DOXYLAMINE SUCCINATE PHENYLEPHRINE HYDROCHLORIDE
acetaminophen dextromethorphan hydrobromide doxylamine succinate phenylephrine hydrochloride capsule, liquid filledProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62207-913 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE 6.25 mg DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 10 mg ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg Inactive Ingredients Ingredient Name Strength SODIUM HYDROXIDE (UNII: 55X04QC32I) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) POVIDONE (UNII: FZ989GH94E) GLYCERIN (UNII: PDC6A3C0OX) GELATIN (UNII: 2G86QN327L) POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SORBITOL (UNII: 506T60A25R) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color green Score no score Shape OVAL Size 20mm Flavor Imprint Code G01 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62207-913-70 8 in 1 BLISTER PACK; Type 0: Not a Combination Product 07/07/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 07/07/2017 Labeler - Granules India Limited (915000087)