NDC | 69256-580-72 |
Set ID | 630f652e-5cae-4ba9-966f-0746bfb084a5 |
Category | HUMAN OTC DRUG LABEL |
Packager | Harris Teeter, LLC |
Generic Name | |
Product Class | alpha-1 Adrenergic Agonist, Antihistamine |
Product Number | |
Application Number | PART341 |
- Active ingredients (in each softgel) – Nighttime Cold & Flu
- Active ingredients (in each softgel) – Daytime Cold & Flu
- Purpose – Nighttime Cold & Flu
- Purpose – Daytime Cold & Flu
- Uses – Nighttime Cold & Flu
- Uses – Daytime Cold & Flu
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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
- •
- 3 or more alcoholic drinks every day while using this product
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
- •
- 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.
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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 – Nighttime Cold & Flu
- Ask a doctor before use if you have – Daytime Cold & Flu
- Ask a doctor or pharmacist before use if you are – Nighttime Cold & Flu
- Ask a doctor or pharmacist before use if you are – Daytime Cold & Flu
- When using this product – Nighttime Cold & Flu
- When using the product – Daytime Cold & Flu
- Stop use and ask a doctor if – Nighttime Cold & Flu
-
Stop use and ask a doctor if – Daytime Cold & Flu
- •
- you get nervous, dizzy or sleepless
- •
- pain, nasal congestion 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.
- If pregnant or breast-feeding,
- Keep out of reach of children.
- Directions – Nighttime Cold & Flu
- Directions – Daytime Cold & Flu
- Other information
- Inactive ingredients – Nighttime Cold & Flu
- Inactive ingredients – Daytime Cold & Flu
- Questions or comments?
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Package/Label Principal Display Panel
Convenience Pack
Compare to the active ingredients in Vicks® DayQuil® Cold & Flu LiquiCaps® and Vicks® NyQuil® Cold & Flu LiquiCaps®
DayTime
Pain Reliever/Fever Reducer
Acetaminophen
Cough Suppressant
Dextromethorphan HBr
Nasal Decongestant
Phenylephrine HCl
COLD & FLU
Multi-Symptom Relief
Aches, Fever, Sore Throat
Nasal Congestion
Cough
Non-Drowsy
Alcohol Free/Antihistamine Free
32 SOFTGELS
Actual Size
NightTime
Pain Reliever/Fever Reducer
Acetaminophen
Cough Suppressant
Dextromethorphan HBr
Antihistamine
Doxylamine Succinate
COLD & FLU
Multi-Symptom Relief
Aches, Fever & Sore Throat
Sneezing, Runny Nose
Cough
16 SOFTGELS
Actual Size
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INGREDIENTS AND APPEARANCE
HARRIS TEETER DAYTIME NIGHTTIME
acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69256-580 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69256-580-72 1 in 1 CARTON; Type 0: Not a Combination Product 11/21/2015 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 8 BLISTER PACK 16 Part 2 16 BLISTER PACK 32 Part 1 of 2 HARRIS TEETER NIGHTTIME
acetaminophen, dextromethorphan hbr, doxylamine succinate capsule, liquid filledProduct Information 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 (UNII: 3WJQ0SDW1A) POVIDONE (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 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 11/21/2015 Part 2 of 2 HARRIS TEETER DAYTIME
acetaminophen, dextromethorphan hbr, phenylephrine hcl capsule, liquid filledProduct Information 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 10 mg PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg Inactive Ingredients Ingredient Name Strength FD&C RED NO. 40 (UNII: WZB9127XOA) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) GELATIN (UNII: 2G86QN327L) GLYCERIN (UNII: PDC6A3C0OX) POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A) POVIDONE (UNII: FZ989GH94E) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SORBITOL (UNII: 506T60A25R) SORBITAN (UNII: 6O92ICV9RU) Product Characteristics Color ORANGE Score no score Shape OVAL Size 20mm Flavor Imprint Code L994 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 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 11/21/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 11/21/2015 Labeler - Harris Teeter, LLC (048463103)