NDC | 70005-005-02, 70005-005-25, 70005-005-50 |
Set ID | a1964f27-6224-4a56-8f2d-3035db1f4a8b |
Category | HUMAN OTC DRUG LABEL |
Packager | We Care Distributor Inc. |
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. The maximum daily dose of this product is 8 softgels (2,600 mg acetaminophen) in 24 hours. 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
Sore throat warning:
If sore throat is severe, lasts for more than 2 days, occurs with or is 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 monomine 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 sleepy
- if you have ever had an allergic reaction to this product or any of its ingredients
Ask a doctor before use if you have
- liver disease
- gloucoma
- a breathing problem such as emphysema or chronic bronchitis
- persistent or chronic cough as occurs with smoking, asthma, or emphysema
- trouble urinating due to an enlarged prostate gland
- cough that occurs with too much phlegm (mucus)
Ask a doctor or pharmacist before use if you are
- taking sedative or tranquilizers
- taking the blood thinning drug warfarin
When using this product
- excitability may occur, especially in children
- be careful when driving a motor vehicle or operating machinery
- avoid alcoholic drinks
- alcohol, sedatives, and tranquilizers may increase drowsiness
- may cause marked drowsiness
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Directions
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take only as directed - see Liver warning
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do not exceed 8 softgels per 24 hours
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adults and children 12 years and over: 2 softgels with water every 6 hours
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children 4 to under 12 years: ask a doctor
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children under 4 years: do not use
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when using other Daytime or Nighttime products, carefully read each label to insure correct dosing
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- Other information
- Inactive ingredients
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Questions or comments?
1-888-705-WECARE (Mon-Fri 9am-5pm EST) or www.wecaredistributor.com
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
NIGHTTIME COLD AND FLU
acetaminophen, dextromethorphan hbr and doxylamine succinate 325 mg, 15 mg and 6.25 mg capsule, liquid filledProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70005-005 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) METHYLPARABEN (UNII: A2I8C7HI9T) POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621) POVIDONE (UNII: FZ989GH94E) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PROPYLPARABEN (UNII: Z8IX2SC1OH) WATER (UNII: 059QF0KO0R) SORBITOL (UNII: 506T60A25R) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color green Score no score Shape OVAL Size 22mm Flavor Imprint Code SN;3 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70005-005-25 25 in 1 BOX 1 2 in 1 POUCH; Type 0: Not a Combination Product 2 NDC:70005-005-50 50 in 1 BOX 2 2 in 1 POUCH; Type 0: Not a Combination Product 3 NDC:70005-005-02 2 in 1 POUCH 3 2 in 1 POUCH; 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 02/17/2016 Labeler - We Care Distributor Inc. (079832998) Establishment Name Address ID/FEI Business Operations Softech Pharma Pvt. Ltd 677111277 manufacture(70005-005)