NDC | 0363-0875-24 |
Set ID | 63a0704a-c30f-fd90-e053-2a91aa0afe29 |
Category | HUMAN OTC DRUG LABEL |
Packager | Walgreens |
Generic Name | |
Product Class | alpha-1 Adrenergic Agonist |
Product Number | |
Application Number | PART341 |
- Active ingredients
- Purpose
- Uses
-
Warnings
Reye’s syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye’s syndrome, a rare but serious illness.
Allergy alert: Aspirin may cause a severe allergic reaction which may include: ■ hives ■ facial swelling ■ asthma (wheezing) ■ shock
Stomach bleeding warning: This product contains a nonsteroidal anti-inflammatory drug (NSAID), which may cause severe stomach bleeding. The chance is higher if you
■ are age 60 or older
■ have had stomach ulcers or bleeding problems
■ take a blood thinning (anticoagulant) or steroid drug
■ take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
■ have 3 or more alcoholic drinks every day while using this product
■ take more or for a longer time than directed
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
■ if you have ever had an allergic reaction to any other pain reliever/fever reducer
■ if you are allergic to aspirin
■ 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.
- Ask a doctor before use if
- Ask a doctor before use if you have
- Ask a doctor or pharmacist before use if you are
-
When using this product
■ do not take more than 8 tablets (adults and children 12 years and over) in a 24-hour period or as directed by doctor.
■ do not use more than directed ■ you may get drowsy ■ avoid alcoholic drinks
■ excitability may occur, especially in children
■ alcohol, sedatives and tranquilizers may increase drowsiness
■ be careful when driving a motor vehicle or operating machinery
-
Stop use and ask a doctor if
■ you experience any of the following signs of stomach bleeding
■ feel faint ■ vomit blood ■ have bloody or black stools ■ have stomach pain that does not get better
■ an allergic reaction occurs. Seek medical help right away. ■ pain or nasal congestion gets worse or lasts more than 7 days
■ fever gets worse or lasts more than 3 days ■ new symptoms occur ■ redness or swelling is present
■ ringing in the ears or a loss of hearing occurs ■ nervousness, dizziness or sleeplessness occurs
- If pregnant or breast-feeding,
- Keep out of reach of children.
- In case of overdose,
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
- PACKAGE LABEL. PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
WALGREENS EFFERVESCENT COLD RELIEF PLUS
aspirin, chlorpheniramine maleate, phenylephrine bitartrate tablet, effervescentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-0875 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 325 mg CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE 2 mg PHENYLEPHRINE BITARTRATE (UNII: 27O3Q5ML57) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE BITARTRATE 7.8 mg Inactive Ingredients Ingredient Name Strength ACESULFAME POTASSIUM (UNII: 23OV73Q5G9) ASPARTAME (UNII: Z0H242BBR1) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) DOCUSATE SODIUM (UNII: F05Q2T2JA0) MANNITOL (UNII: 3OWL53L36A) POVIDONE K30 (UNII: U725QWY32X) SODIUM BENZOATE (UNII: OJ245FE5EU) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Product Characteristics Color white Score no score Shape ROUND Size 25mm Flavor LEMON Imprint Code CF Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0363-0875-24 24 in 1 CARTON 09/14/2017 12/31/2021 1 2 in 1 POUCH; 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 10/24/2014 12/31/2021 Labeler - Walgreens (008965063)