NDC | 11673-626-62, 11673-626-67 |
Set ID | f473bb8b-9466-4123-b476-0b686474ae0a |
Category | HUMAN OTC DRUG LABEL |
Packager | Target Corporation |
Generic Name | |
Product Class | Antihistamine |
Product Number | |
Application Number | PART341 |
- Active ingredients (in each softgel)
- Purpose
- Uses
-
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
- •
- more than 4,000 mg of acetaminophen in 24 hours
- •
- with other drugs containing acetaminophen
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- 3 or more alcoholic drinks every day while using this product
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
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- skin reddening
- •
- blisters
- •
- rash
If a skin reaction occurs, stop use and seek medical help right away.
Sore throat warning: If sore throat is severe, lasts 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 have ever had an allergic reaction to this product or any of its ingredients
Ask a doctor before use if you have
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- liver disease
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- glaucoma
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- cough that occurs with too much phlegm (mucus)
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- 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
Ask a doctor or pharmacist before use if you are
- •
- taking sedatives or tranquilizers
- •
- taking the blood thinning drug warfarin
When using this product
- •
- 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
- Keep out of reach of children.
- Directions
- Inactive ingredients
-
Package/Label Principal Display Panel
Compare to active ingredients in Vick® NyQuil® Cold & Flu LiquiCaps®
nighttime cold and flu
nighttime relief
acetaminophen (pain reliever/fever reducer)
dextromethorphan HBr (cough suppressant)
doxylamine succinate (antihistamine)
aches
fever and sore throat
sneezing and runny nose
cough
ACTUAL SIZE
24 SOFTGELS
24 SOFTGELS
-
INGREDIENTS AND APPEARANCE
UP AND UP NIGHTTIME COLD AND FLU
acetaminophen, dextromethorphan hbr, doxylamine succinate capsule, liquid filledProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11673-626 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, UNSPECIFIED (UNII: 2G86QN327L) GLYCERIN (UNII: PDC6A3C0OX) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SORBITOL (UNII: 506T60A25R) SORBITAN (UNII: 6O92ICV9RU) Product Characteristics Color GREEN (clear) Score no score Shape OVAL Size 20mm Flavor Imprint Code 056 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11673-626-67 24 in 1 CARTON 02/11/2015 12/31/2021 1 2 in 1 BLISTER PACK; Type 0: Not a Combination Product 2 NDC:11673-626-62 12 in 1 CARTON 02/11/2015 12/31/2021 2 2 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 02/11/2015 12/31/2021 Labeler - Target Corporation (006961700)