NDC | 37012-480-20, 37012-480-24 |
Set ID | d08d5ef8-e0bf-4ef0-9f90-4e30d9828bc3 |
Category | HUMAN OTC DRUG LABEL |
Packager | Shopko Stores Operating Co., LLC. |
Generic Name | |
Product Class | Antihistamine |
Product Number | |
Application Number | PART341 |
- Active ingredients (in each softgel)
- Purpose
- 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, persists for more than 2 days, 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 when driving a motor vehicle or operating machinery
- alcohol, sedatives and tranquilizers may increase drowsiness
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.
Keep out of reach of children.
Overdose warning: Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults and for children even if you do not notice any signs or symptoms.
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Directions
- take only as directed – see Overdose warning
- do not exceed 4 doses per 24 hours
adults and children 12 years and over swallow 2 softgels with water every 6 hours children 4 to under 12 years ask a doctor children under 4 years do not use - when using other Day time or Night time products, carefully read each label to insure correct dosing
- Other information
- Inactive ingredients
- Questions or comments?
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Principal Display Panel
SHOPKO®
*Compare to the Vicks® Nyquil® active ingredients
*This product is not manufactured or distributed by Procter & Gamble, owner of the registered trademark Vicks® Nyquil®
Night time Cold/ flu relief Multi- symptom
Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine succinate.
Pain reliever/ fever reducer
cough suppressant
Antihistamine
Packaged by:
PL Developments
200 hIcks street
westbury, NY 11590
THIS PRODUCT IS PACKAGED IN A CHILD RESISTANT AND TAMPER EVIDENT PACKAGE. USE ONLY IF BLISTERS ARE INTACT.
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION
- Product Label
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INGREDIENTS AND APPEARANCE
NIGHT TIME COLD/FLU RELIEF MULTI SYMPTOM
acetaminophen, dextromethorphan hydrobromide, doxylamine succinate capsule, liquid filledProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:37012-480 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 GLYCOLS (UNII: 3WJQ0SDW1A) POVIDONES (UNII: FZ989GH94E) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SORBITAN (UNII: 6O92ICV9RU) SORBITOL (UNII: 506T60A25R) Product Characteristics Color GREEN Score no score Shape CAPSULE Size 20mm Flavor Imprint Code P30;94A;35A Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:37012-480-24 2 in 1 CARTON 1 12 in 1 BLISTER PACK 2 NDC:37012-480-20 2 in 1 CARTON 2 10 in 1 BLISTER PACK Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part341 08/30/2012 Labeler - Shopko Stores Operating Co., LLC. (023252638)