Label: ALGIDOL FLU- acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride, doxylamine succinate kit
- NDC Code(s): 69377-003-01, 69377-004-01, 69377-005-01
- Packager: Gelpharma S.A. de C.V.
- Category: HUMAN OTC DRUG LABEL
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated October 4, 2022
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Active ingredients (in each softgel capsule)
- Uses
-
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
- more than 8 capsules in 24 hours, which is the maximum daily amount
- 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.
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.
- for persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema, or where cough is accompanied by excessive phlegm (mucus) unless directed by a doctor.
- if you have heart disease, high blood pressure, thyroid disease, diabetes, or difficulty in urination due to enlargement of the prostate gland unless directed by a doctor.
When using this product
- do not exceed the recommended dosage
- do not take this product for pain for more than 10 days or for fever for more than 3 days unless directed by a doctor. If pain or fever persists or gets worse, if new symptoms occur, or if redness or swelling is present, consult a doctor because these could be signs of a serious condition.
- 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.
- if symptoms do not improve within 7 days or are accompanied by fever, consult a doctor.
Stop use and ask a doctor if
- pain or nasal decongestion 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 persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition.
- if nervousness, dizziness, or sleeplessness occur
- Directions
- Other information
- Inactive ingredients
- Drug Facts
- Active ingredients (in each softgel capsule)
-
Uses
- temporarily relieves
- minor aches and pains associated with the common cold, sore throat, or headache
- cough associated with the common cold
- nasal congestion due to the common cold
- runny nose and alleviates sneezing, itching of the nose or throat, and itchy, watery eyes due to hay fever
- temporarily reduces fever
-
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
- more than 8 capsules in 24 hours, which is the maximum daily amount
- 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.
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.
- for persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema, or where cough is accompanied by excessive phlegm (mucus) unless directed by a doctor.
- if you have heart disease, high blood pressure, thyroid disease, diabetes, a breathing problem such as emphysema or chronic bronchitis, or difficulty in urination due to enlargement of the prostate gland unless directed by a doctor.
When using this product
- do not exceed the recommended dosage
- do not take this product for pain for more than 10 days or for fever for more than 3 days unless directed by a doctor. because these could be signs of a serious condition.
- 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.
- if symptoms do not improve within 7 days or are accompanied by fever, consult a doctor.
- may cause excitability especially in children
- may cause marked drowsiness; alcohol, sedatives, and tranquilizers may increase the drowsiness effect. Avoid alcoholic beverages while taking this product. Do not take this product if you are taking sedatives or tranquilizers, without first consulting your doctor. Use caution when driving a motor vehicle or operating machinery.
Stop use and ask a doctor if
- pain or nasal decongestion 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 persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition.
- if nervousness, dizziness, or sleeplessness occur
- Directions
- Other information
- Inactive ingredients
- Package Labeling:
-
INGREDIENTS AND APPEARANCE
ALGIDOL FLU
acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride, doxylamine succinate kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69377-003 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69377-003-01 1 in 1 CARTON 09/01/2022 1 1 in 1 KIT Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 0 CAPSULE 2 Part 2 0 CAPSULE 1 Part 1 of 2 ALGIDOL DAYTIME
acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride capsuleProduct Information Item Code (Source) NDC:69377-004 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 GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 200 mg PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE 5 mg Inactive Ingredients Ingredient Name Strength GELATIN (UNII: 2G86QN327L) WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9) POVIDONE K30 (UNII: U725QWY32X) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U) Product Characteristics Color orange Score no score Shape OVAL Size 10mm Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69377-004-01 2 in 1 BLISTER PACK 1 8 in 1 CAPSULE; 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 09/01/2022 Part 2 of 2 ALGIDOL NIGHTTIME
acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride capsuleProduct Information Item Code (Source) NDC:69377-005 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 DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE 6.25 mg PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE 5 mg Inactive Ingredients Ingredient Name Strength GELATIN (UNII: 2G86QN327L) WATER (UNII: 059QF0KO0R) POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621) GLYCERIN (UNII: PDC6A3C0OX) POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) POVIDONE K30 (UNII: U725QWY32X) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U) Product Characteristics Color green Score no score Shape OVAL Size 9mm Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69377-005-01 1 in 1 BLISTER PACK 1 8 in 1 CAPSULE; 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 09/01/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 09/01/2022 Labeler - Gelpharma S.A. de C.V. (812773665)