NDC | 68210-0105-1 |
Set ID | 6e980c7c-23bb-4c89-b503-0f92fcf0892c |
Category | HUMAN OTC DRUG LABEL |
Packager | SPIRIT PHARMACEUTICALS LLC |
Generic Name | |
Product Class | Antihistamine |
Product Number | |
Application Number | PART341 |
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- Uses
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Warnings
Liver warning
This product contains acetaminophen. Severe liver damage may occur if you take:
- more than 4 doses 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
Sore throat warning
If sore throat is severe, lasts for more than 2 days, or occurs with or is followed by fever, headache, rash, nausea, or vomiting, see 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.
- to make a child sleep
Ask a doctor before use if you have
- liver disease
- glaucoma
- 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
- trouble urinating due to enlarged prostate gland
Ask a doctor or pharmacist before use if you are
- taking sedatives or tranquilizers
- taking the blood-thinning drug warfarin.
When using this product
- do not use more than directed
- excitability may occur especially in children
- marked drowsiness may occur
- avoid alcoholic drinks
- be careful with driving a motor vehicle or operating machinery
- alcohol, sedatives and tranquilizers may increase drowsiness
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Directions
- Take only as recommended—see Overdose warning.
- do not exceed 4 doses per 24 hours
adults and children 12 years of age and over swallow 2 softgels with water every 6 hours children 4 to under 12 years of age ask a doctor children under 4 years of age do not use
If taking Nighttime and Daytime softgels carefully read each label to insure correct dosing
- Other information
- Inactive ingredients
- Questions or comments?
- SPL UNCLASSIFIED SECTION
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PRINCIPAL DISPLAY PANEL - 10 Capsule Blister Pack Carton
ASSURED™
COMPARE TO ACTIVE INGREDIENTS IN
VICKS® NYQUIL®*MULTI-SYMPTOM
NiteTime
Liquid Capsules
- Acetaminophen - Pain Reliever / Fever Reducer
- Dextromethorphan HBr - Cough Suppressant
- Doxylamine Succinate - Antihistamine
Fever, Headache, Sore Throat,
Coughing, Minor Aches and Pains,
Runny Nose & SneezingActual Size
10 softgels
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INGREDIENTS AND APPEARANCE
MULTI-SYMPTOM NITETIME
acetaminophen, dextromethorphan hydrobromide, and doxylamine succinate capsule, liquid filledProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68210-0105 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 15 mg DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE 6.25 mg Inactive Ingredients Ingredient Name Strength D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) GELATIN (UNII: 2G86QN327L) GLYCERIN (UNII: PDC6A3C0OX) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) POVIDONE K30 (UNII: U725QWY32X) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SORBITOL (UNII: 506T60A25R) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color green Score no score Shape CAPSULE (SOFTGELS) Size 20mm Flavor Imprint Code 215 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68210-0105-1 1 in 1 CARTON 02/20/2016 1 10 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 02/20/2016 Labeler - SPIRIT PHARMACEUTICALS LLC (179621011) Establishment Name Address ID/FEI Business Operations MEDGEL PRIVATE LTD 677385498 manufacture(68210-0105)