Label: DAYTIME NIGHTTIME COLD AND FLU RELIEF COMBO PACK- daytime nighttime cold and flu kit
- NDC Code(s): 69168-417-93, 69168-418-86, 69168-438-15
- Packager: Allegiant Health
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated May 19, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient(s)
- Purpose
-
Use(s)
DAYTIME ONLY
temporarily relieves common cold/flu symptoms: • nasal
congestion • cough due to minor throat & bronchial irritation • sore
throat • headache • minor aches & pains • feverNIGHTTIME ONLY
temporarily relieves common cold/flu symptoms:
• cough due to minor throat & bronchial irritation • sore throat • headache
• minor aches & pains • fever • runny nose & sneezing -
Warnings
DAYTIME AND NIGHTTIME
Liver warning: This product contains acetaminophen.
Severe liver damage may occur if you take:
• more than 4 doses in 24 hrs, which is the maximum daily amount for this product
• with other drugs containing acetaminophen
• 3 or more alcoholic drinks every day while using this productAllergy 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, persists for more than 2 days,
occurs with or is followed by fever, headache, rash, nausea, or vomiting,
consult a doctor promptly.Do not use
DAYTIME 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.NIGHTTIME 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.
• to make a child sleepAsk a doctor before use if you have
DAYTIME ONLY
• liver disease • heart disease • thyroid disease • diabetes • high blood pressure
• trouble urinating due to an enlarged prostate gland • cough that occurs
with too much phlegm (mucus) • persistent or chronic cough as occurs
with smoking, asthma, or emphysemaNIGHTTIME ONLY
• 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 glandAsk a doctor or pharmacist before use if
DAYTIME ONLY
taking the blood thinning drug warfarin.
NIGHTTIME ONLY
• taking sedatives or tranquilizers
• taking the blood thinning drug warfarin
When using this product
DAYTIME ONLY
do not use more than directed
NIGHTTIME ONLY
• 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 & tranquilizers may increase drowsiness
Stop use and ask a doctor if
DAYTIME ONLY
• you get nervous, dizzy or sleepless
• symptoms get worse or last more than 5 days (children) or 7 days (adults)
• 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.NIGHTTIME ONLY
• 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.
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Directions
DAYTIME ONLY
- Take only as directed
- Do not exceed 4 doses in 24 hrs
adults and children 12 yrs & over: 2 softgels with water every 4 hrs
children 4 to under 12 yrs: ask a doctor
children under 4 yrs: do not use
NIGHTTIME ONLY
- Take only as directed
- Do not exceed 4 doses in 24 hrs
adults and children 12 yrs & over: 2 softgels with water every 6 hrs
children 4 to under 12 yrs: ask a doctor
children under 4 yrs: do not use
- Other information
-
Inactive ingredients
DAYTIME ONLY
FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, povidone, propylene
glycol, purified water, sorbitol sorbitan solution, white edible inkNIGHTTIME ONLY
D&C yellow #10, FD&C blue #1, gelatin, glycerin, polyethylene glycol, povidone, propylene
glycol, purified water, sorbitol sorbitan solution, white edible ink
- Questions
- Principal Display Panel
-
INGREDIENTS AND APPEARANCE
DAYTIME NIGHTTIME COLD AND FLU RELIEF COMBO PACK
daytime nighttime cold and flu kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69168-438 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69168-438-15 1 in 1 CARTON; Type 0: Not a Combination Product 05/20/2022 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 2 BLISTER PACK 24 Part 2 1 BLISTER PACK 12 Part 1 of 2 DAYTIME COLD AND FLU
acetaminophen 325mg/ dextromethorphan hbr 10mg/ phenylephrine hcl 5mg capsuleProduct Information Item Code (Source) NDC:69168-417 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, UNSPECIFIED (UNII: 3WJQ0SDW1A) POVIDONE (UNII: FZ989GH94E) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SORBITOL SOLUTION (UNII: 8KW3E207O2) Product Characteristics Color orange Score no score Shape CAPSULE Size 21mm Flavor Imprint Code PC9 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69168-417-93 2 in 1 CARTON 1 12 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 Drug M012 05/20/2022 Part 2 of 2 NIGHTTIME COLD AND FLU RELIEF
acetaminophen capsuleProduct Information Item Code (Source) NDC:69168-418 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) SORBITOL SOLUTION (UNII: 8KW3E207O2) Product Characteristics Color green Score no score Shape CAPSULE Size 20mm Flavor Imprint Code PC10 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69168-418-86 1 in 1 CARTON 1 12 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 Drug M012 05/20/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M012 05/20/2022 Labeler - Allegiant Health (079501930)