Label: RESFRIOL D- acetaminophen, chlorpheniramine maleate, phenylephrine hcl tablet
- NDC Code(s): 69729-323-27, 69729-323-37, 69729-323-38
- Packager: OPMX LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated January 26, 2024
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- ACTIVE INGREDIENT
- PURPOSE
-
INDICATIONS & USAGE
Uses:
- temporarily relieves these symptoms of hay fever or other respiratory allergies:
- headache
- sinus congestion & pressure
- nasal congestion
- runny nose and sneezing
- minor aches & pain
- temporarily relieves these additional symptoms of hay fever:
- nose or throat itching
- itchy, watery eyes
- helps clear nasal passages
- helps decongest sinus opening and passages
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WARNINGS
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take :
- more than 6 tablets in 24 hours, which is the maximum daily amount for this product
- with other drugs contains 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, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult 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 drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
- if you have ever had an allergic reaction to this product or any of its ingredients
- to make a child sleepy
Ask a doctor before use if you have:
- liver disease
- heart disease
- high blood pressure
- thyroid disease
- glaucoma
- diabetes
- trouble urinating due to enlarged prostate gland
- a breathing problem such as emphysema or chronic bronchitis
Ask a doctor or pharmacist before use if you are:
- taking the blood thinning drug warfarin
- taking sedatives or tranquilizers
When using this product:
- do not use more than directed
- excitability may occur, especially in children
- drowsiness may occur
- alcohol, sedatives and tranquilizers may increase drowsiness
- avoid alcoholic drinks
- be careful when driving a motor vehicle or operating machinery
Stop use and ask a doctor if:
- nervousness, dizziness, or sleeplessness occur
- pain or nasal congestion gets worse or lasts more than 7 days
- fever gets worse or last more than 3 days
- redness or swelling is present
- new symptoms occur
These could be signs of a serious condition.
Keep out of reach of children.
Overdose warning:Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt 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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DOSAGE & ADMINISTRATION
Directions:
- Do not take more than directed - see overdose warning
- Swallow whole; do not crush, chew or dissolve
- Do not exceed 6 tablets per 24 hours
Adults and children 12 years of age & over 1 tablet with water every 4-6 hours as needed Children 4 to 12 years of age Ask a doctor Children under 4 years of age Do not use - STORAGE AND HANDLING
- INACTIVE INGREDIENT
- QUESTIONS
- SPL UNCLASSIFIED SECTION
-
PRINCIPAL DISPLAY PANEL - 144 TABLETS
NDC 69729-323-38
RESFRIOL D
Actaminophen 500 mg - Pain reliever/Fever Reducer
Chlorpheniramine Maleate 4 mg - Antihistamine
Phenylephrine HCl 10 mg - Nasal decongestant
Cold/Allergy Relief
To relieve common symptoms of Cold & Allergy such as:
Headache
Sneezing
Nasal Congestion
Itchy, Watery Eyes and Runny Nose
144 Tablets (72 Pouches of 2 tablets)
-
PRINCIPAL DISPLAY PANEL - 12 TABLETS
NDC 69729-323-37
RESFRIOL D
Actaminophen 500 mg - Pain reliever/Fever Reducer
Chlorpheniramine Maleate 4 mg - Antihistamine
Phenylephrine HCl 10 mg - Nasal decongestant
Cold/Allergy Relief
To relieve common symptoms of Cold & Allergy such as:
Headache
Sneezing
Nasal Congestion
Itchy, Watery Eyes and Runny Nose
12 Tablets (6 Pouches of 2 tablets)
-
PRINCIPAL DISPLAY PANEL - 2 Tablets
NDC 69729-323-27
RESFRIOL D
Actaminophen 500 mg - Pain reliever/Fever Reducer
Chlorpheniramine Maleate 4 mg - Antihistamine
Phenylephrine HCl 10 mg - Nasal decongestant
Cold/Allergy Relief
To relieve common symptoms of Cold & Allergy such as:
Headache
Sneezing
Nasal Congestion
Itchy, Watery Eyes and Runny Nose
2 Tablets
-
INGREDIENTS AND APPEARANCE
RESFRIOL D
acetaminophen, chlorpheniramine maleate, phenylephrine hcl tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69729-323 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 10 mg ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 500 mg CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE 4 mg Inactive Ingredients Ingredient Name Strength CROSPOVIDONE, UNSPECIFIED (UNII: 2S7830E561) TALC (UNII: 7SEV7J4R1U) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) MAGNESIUM STEARATE (UNII: 70097M6I30) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) Product Characteristics Color white Score no score Shape ROUND Size 13mm Flavor Imprint Code A15 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69729-323-38 72 in 1 CARTON 01/10/2024 1 2 in 1 POUCH; Type 0: Not a Combination Product 2 NDC:69729-323-37 6 in 1 CARTON 01/10/2024 2 2 in 1 POUCH; Type 0: Not a Combination Product 3 NDC:69729-323-27 2 in 1 POUCH; Type 0: Not a Combination Product 01/10/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M012 01/10/2024 Labeler - OPMX LLC (029918743) Establishment Name Address ID/FEI Business Operations Vovantis Laboratories Private Limited 650502151 manufacture(69729-323)