DAYTIME NITETIME COLD FLU RELIEF- acetaminophen, dextromethorphan hbr, phenylephrine hcl, doxylamine succinate kit

DayTime NiteTime Cold Flu Relief by

Drug Labeling and Warnings

DayTime NiteTime Cold Flu Relief by is a Otc medication manufactured, distributed, or labeled by Care One (American Sales Company). Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients for Daytime (in each softgel)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg

Active ingredients for Nitetime (in each softgel)

Acetaminophen 325 mg

Dextromethorphan HBr 15 mg

Doxylamine succinate 6.25 mg

Purpose for Daytime

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

Purpose for Nitetime

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Uses

• temporarily relieves common cold and flu symptoms:
  • sore throat
  • headache
  • minor aches and pains
  • fever
  • cough due to minor throat and bronchial irritation
  • nasal congestion (Daytime only)
  • runny nose and sneezing (Nitetime only)

Warnings

Liver warning: These products contain 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

Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Do not use

• to make a child sleep (Nitetime only)
• 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.

Ask a doctor before use if you have

• liver disease
• cough that occurs with too much phlegm (mucus)
• trouble urinating due to an enlarged prostate gland
• persistent or chronic cough such as occurs with smoking, asthma, emphysema, and (for Nitetime only) chronic bronchitis
• glaucoma (Nitetime only)
• diabetes (Daytime only)
• heart disease (Daytime only)
• thyroid disease (Daytime only)
• high blood pressure (Daytime only)

Ask a doctor or pharmacist before use if you are

• taking the blood thinning drug warfarin
• taking sedatives or tranquilizers (Nitetime only)

When using this product,

do not use more than directed.

In addition, when using Nitetime:

• excitability may occur, especially in children
• avoid alcoholic drinks
• marked drowsiness may occur
• alcohol, sedatives, and tranquilizers may increase drowsiness
• be careful when driving a motor vehicle or operating machinery

Stop use and ask a doctor if

• nervousness, dizziness, or sleeplessness occur (Daytime only)
• pain, cough, and (for Daytime only) nasal congestion 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,

ask a health professional before use.

Keep out of reach of children.

Overdose warning: Taking more than the recommended dose can cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

• do not take more than directed (see Overdose warning )
• do not take more than 4 doses in 24 hours
• swallow whole; do not crush, chew, or dissolve

Daytime: adults and children 12 years and over: take 2 softgels with water every 4 hours

Nitetime: adults and children 12 years and over: take 2 softgels with water every 6 hours

• children under 12 years: do not use

Other information

• store at room temperature 15°-30°C (59°-86°F)
• avoid excessive heat

Inactive ingredeints for Daytime

butylated hydroxyanisole, butylated hydroxytoluene, edible white ink, FD&C red #40*, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitan, sorbitol

*may contain this ingredient

Inactive ingredients for Nitetime

D&C yellow #10, edible white ink, FD&C blue #1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitan sorbitol

Questions or comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel - 48 Capsule Kit Carton

Compare to the Active Ingredients in Vicks® DayQuil® and NyQuil® LiquiCaps®†

NON-DROWSY DAYTIME / MULTI-SYMPTOM NITETIME

COLD/FLU RELIEF LIQUID CAPS

Acetaminophen - Pain Reliever-Fever Reducer / Acetaminophen - Pain Reliever-Fever Reducer

Dextromethorphan HBr - Cough Suppressant / Dextromethorphan HBr - Cough Suppressant

Phenylephrine HCl - Nasal Decongestant / Doxylamine Succinate - Antihistamine

DAYTIME SOFTGELS / NITETIME SOFTGELS

Alcohol Free

Antihistamine Free

When using Daytime and Nitetime products, carefully read the labeling to insure correct dosing

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.

DISTRIBUTED BY

FOODHOLD U.S.A., LLC

LANDOVER, MD 20785

†This product is not manufactured or distributed by Procter & Gamble, owner of the registered trademark Vicks® DayQuil® and NyQuil® Liqui

Product Label

Care One Daytime/Nitetime Cold Flu Relief Softgels

INGREDIENTS AND APPEARANCE

DAYTIME NITETIME COLD FLU RELIEF 
acetaminophen, dextromethorphan hbr, phenylephrine hcl, doxylamine succinate kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41520-446

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41520-446-48	1 in 1 CARTON; Type 0: Not a Combination Product	10/30/2014	10/30/2020

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

NITETIME COLD FLU RELIEF 
acetaminophen, dextromethorphan hydrobromide, doxylamine succinate capsule

Product Information
Item Code (Source)	NDC: 41520-000
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, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE (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;SCU1
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41520-000-16	8 in 1 CARTON
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	10/30/2014	10/30/2020

Part 2 of 2

DAYTIME COLD FLU RELIEF 
acetaminophen, dextromethorphan hbr, phenylephrine hcl capsule

Product Information
Item Code (Source)	NDC: 41520-010
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
BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE (UNII: FZ989GH94E)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SORBITAN (UNII: 6O92ICV9RU)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color	ORANGE	Score	no score
Shape	CAPSULE	Size	20mm
Flavor		Imprint Code	P19;95A
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41520-010-32	16 in 1 CARTON
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	10/30/2014	10/30/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	10/30/2014	10/30/2020

Labeler - Care One (American Sales Company) (809183973)