DAYTIME NIGHTTIME COLD FLU RELIEF- acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl 
APNAR PHARMA LP

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DAYTIME NIGHTTIME COLD FLU RELIEF

Active ingredients for Daytime (in each softgel)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg

Active ingredients for Nighttime (in each softgel)

Acetaminophen 325 mg

Dextromethorphan HBr 15 mg

Doxylamine succinate 6.25 mg

Purposes

for Daytime

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

Purposes

for Nighttime

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Uses

Daytime

Uses

Nighttime

Warnings

Daytime

Liver warning: These products contain acetaminophen. Severe liver damage may occur if you take:

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

If a skin reaction occurs, stop use and seek medical help right away

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.

Nighttime

Liver warning: These products contain acetaminophen. Severe liver damage may occur if you take:

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

If a skin reaction occurs, stop use and seek medical help right away

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

Daytime

Nighttime

Ask a doctor before use if you have

Daytime

Nighttime

Ask a doctor or pharmacist before use if you are

Daytime

taking the blood thinning drug warfarin

Nighttime

When using this product

Daytime

do not exceed recommended dosage

Nighttime

Stop use and ask a doctor if

Daytime

These could be signs of a serious condition.

Nighttime

These could be a 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 (1-800-222- 1222) 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

Daytime

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

children under 12 years: do not use

Nighttime

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

children under 12 years: do not use

Other information

Inactive ingredients

Daytime

Gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitan, sorbitol, FD&C yellow #6, FD&C Red #40 , white ink

Nighttime

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

Questions or comments?

Call 1-855-642-2594

†Compare to the active ingredients in Vicks® DayQuil® and NyQuil® Cold & Flu LiquiCaps®

Daytime

NDC 24689-152-01

Multi-Symptom Cold & Flu Relief

Acetaminophen 325 mg- Pain reliever / Fever reducer

Dextromethorphan HBr 10 mg - Cough suppressant

Phenylephrine HCI 5 mg - Nasal decongestant

Relieves:

Non-drowsy

Alcohol-Free

Antihistamine-Free

Softgels**

(** Liquid-filled capsules)

Nighttime

Multi-Symptom Cold & Flu Relief

Acetaminophen 325 mg - Pain reliever / Fever reducer

Dextromethorphan HBr 15 mg - Cough suppressant

Doxylamine succinate 6.25 mg - Antihistamine

Relieves:

Softgels**

Alcohol-free

(**Liquid-filled capsules)

When using Daytime and Nighttime products, carefully read the labeling to ensure correct dosing.

†This product is not manufactured or distributed by The Procter & Gamble Company.

Vicks®, DayQuil®, NyQuil®, and LiquiCaps® are registered trademarks of the Procter and Gamble Company.

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

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

Distributed by:

APNAR PHARMA LP

CHINO, CA, USA, 91710

Rev.: 04/2023

Daytime and Nighttime Soft Gel-Carton-label

DAYTIME NIGHTTIME COLD FLU RELIEF 
acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24689-152
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:24689-152-011 in 1 CARTON; Type 0: Not a Combination Product05/11/2023
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 116 BLISTER PACK 16 
Part 232 BLISTER PACK 32 
Part 1 of 2
NIGHTTIME COLD FLU RELIEF 
acetaminophen, dextromethorphan hbr, doxylamine succinate capsule
Product Information
Item Code (Source)NDC:24689-157
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE6.25 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE15 mg
Inactive Ingredients
Ingredient NameStrength
SORBITAN (UNII: 6O92ICV9RU)  
POVIDONE (UNII: FZ989GH94E)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
SORBITOL (UNII: 506T60A25R)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
GLYCERIN (UNII: PDC6A3C0OX)  
GELATIN (UNII: 2G86QN327L)  
Product Characteristics
ColorgreenScoreno score
ShapeCAPSULESize23mm
FlavorImprint Code AA7
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
116 in 1 CARTON
11 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01205/11/2023
Part 2 of 2
DAYTIME COLD FLU RELIEF 
acetaminophen, dextromethorphan hbr, phenylephrine hcl capsule
Product Information
Item Code (Source)NDC:24689-158
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
SORBITOL (UNII: 506T60A25R)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SORBITAN (UNII: 6O92ICV9RU)  
GELATIN (UNII: 2G86QN327L)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
GLYCERIN (UNII: PDC6A3C0OX)  
POVIDONE (UNII: FZ989GH94E)  
Product Characteristics
ColorredScoreno score
ShapeCAPSULESize23mm
FlavorImprint Code AA6
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
132 in 1 CARTON
11 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01205/11/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01205/11/2023
Labeler - APNAR PHARMA LP (079568229)
Establishment
NameAddressID/FEIBusiness Operations
APNAR PHARMA LLP118530917manufacture(24689-152) , analysis(24689-152)

Revised: 10/2023
Document Id: 08358a96-cb92-14cd-e063-6394a90ac029
Set id: f3d9d25b-486d-c693-e053-2a95a90a533b
Version: 2
Effective Time: 20231021
 
APNAR PHARMA LP