Label: DAY AND NIGHT MULTI SYMPTOM COLD AND FLU RELIEF kit
- NDC Code(s): 83558-020-02, 83558-021-01
- Packager: Intrivo Diagnostics Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated October 13, 2023
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)
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Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take- more than 4 doses in 24 hours, which is the maximum daily amount for this product
- 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, occurs with or followed by fever, headache, rash,
nausea, or vomiting, see 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 drugs. 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 sleep (Nighttime only)
Ask a doctor before use if
- liver disease
- 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 an enlarged prostate gland
- glaucoma (Nighttime only)
- heart disease
- thyroid disease
- diabetes high blood sugar (Daytime only)
Ask a doctor or pharmacist before use if
you are taking the blood thinning drug warfarin
- taking sedatives or tranquilizers (Nighttime only)
When using this product
When using this product
- do not use more than directed
- excitability may occur, especially in children
- marked drowsiness may occur
- avoid alcoholic drink
- be careful when driving a motor vehicle or operating machinery
- alcohol, sedatives, and tranquilizers may increase drowsiness
Stop use and ask a doctor if
- pain 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.
- you get nervous, dizzy or sleepless
- symptoms get worse or last more than 5 days (children) or 7 days (adults) (Daytime only)
These could be signs of a serious condition.
Keep out of reach of children
Taking more than directed can cause serious health problems. 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.
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Directions
Directions (Nighttime only)
- take only as directed
- do not exceed 4 doses per 24 hours
Adults and children 12 years and over: 2 softgels with water every 4 hours
Children 4 to under 12 years: do not use
Children under 4 years: ask a doctor
Directions (Daytime only)
- take only as directed
- do not exceed 4 doses per 24 hours
Adults and children 12 years and over: 2 softgels with water every 6 hours
Children 4 to under 12 years: do not use
Children under 4 years: ask a doctor
- Other information
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Inactive ingredients
Inactive ingredients (Nighttime only)
D&C yellow #10, FD&C blue #1, gelatin, glycerin, polyethylene glycol,
povidone, propylene glycol, purified water, sorbitol sorbitan
solution, white edible inkInactive 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 ink - Questions/Comments
- Principal Display Panel
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INGREDIENTS AND APPEARANCE
DAY AND NIGHT MULTI SYMPTOM COLD AND FLU RELIEF
day and night multi symptom cold and flu relief kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:83558-020 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:83558-020-02 2 in 1 CARTON 10/28/2023 1 1 in 1 CARTON; Type 0: Not a Combination Product Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 BLISTER PACK 10 Part 2 1 BLISTER PACK 10 Part 1 of 2 DAYTIME COLD AND FLU RELIEF
daytime cold and flu relief capsule, liquid filledProduct Information Item Code (Source) NDC:83558-021 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:83558-021-01 1 in 1 CARTON 1 10 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 10/28/2023 Part 2 of 2 NIGHTTIME COLD AND FLU RELIEF
nighttime cold and flu relief capsule, liquid filledProduct Information Item Code (Source) NDC:83558-022 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 21mm Flavor Imprint Code PC10 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 1 in 1 CARTON 1 10 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 10/28/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M012 10/28/2023 Labeler - Intrivo Diagnostics Inc. (118833259)
