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NDC 41163-0768-20 Equaline Effervescent Cold Relief 325; 2; 7.8 mg/1; mg/1; mg/1 Details
Equaline Effervescent Cold Relief 325; 2; 7.8 mg/1; mg/1; mg/1
Equaline Effervescent Cold Relief is a ORAL TABLET, EFFERVESCENT in the HUMAN OTC DRUG category. It is labeled and distributed by Supervalu Inc.. The primary component is ASPIRIN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE BITARTRATE.
Product Information
NDC | 41163-0768 |
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Product ID | 41163-768_c0f499c5-a219-6222-e053-2a95a90a91ac |
Associated GPIs | |
GCN Sequence Number | n/a |
GCN Sequence Number Description | n/a |
HIC3 | n/a |
HIC3 Description | n/a |
GCN | n/a |
HICL Sequence Number | n/a |
HICL Sequence Number Description | n/a |
Brand/Generic | n/a |
Proprietary Name | Equaline Effervescent Cold Relief |
Proprietary Name Suffix | n/a |
Non-Proprietary Name | Aspirin, Chlorpheniramine Maleate, Phenylephrine Bitartrate |
Product Type | HUMAN OTC DRUG |
Dosage Form | TABLET, EFFERVESCENT |
Route | ORAL |
Active Ingredient Strength | 325; 2; 7.8 |
Active Ingredient Units | mg/1; mg/1; mg/1 |
Substance Name | ASPIRIN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE BITARTRATE |
Labeler Name | Supervalu Inc. |
Pharmaceutical Class | Adrenergic alpha1-Agonists [MoA], Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor An |
DEA Schedule | n/a |
Marketing Category | OTC MONOGRAPH FINAL |
Application Number | part341 |
Listing Certified Through | 2024-12-31 |
Package
Package Images

NDC 41163-0768-20 (41163076820)
NDC Package Code | 41163-768-20 |
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Billing NDC | 41163076820 |
Package | 10 POUCH in 1 CARTON (41163-768-20) / 2 TABLET, EFFERVESCENT in 1 POUCH |
Marketing Start Date | 2019-09-24 |
NDC Exclude Flag | N |
Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 6bf341e0-94b1-08ff-e053-2991aa0af634 Details
Active ingredients
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
■ stomach bleeding warning applies to you ■ you have a history of stomach problems, such as heartburn ■ you have high blood pressure, heart disease, liver cirrhosis, or kidney disease ■ you are taking a diuretic. ■ you are taking sedatives or tranquilizers.
You have ■ glaucoma ■ diabetes ■ thyroid disease ■ trouble urinating due to an enlarged prostate gland ■ a breathing problem such as emphysema or chronic bronchitis ■ been placed on a sodium-restricted diet
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
In case of overdose
Directions
Other information
Inactive ingredients
INGREDIENTS AND APPEARANCE
EQUALINE EFFERVESCENT COLD RELIEF
aspirin, chlorpheniramine maleate, phenylephrine bitartrate tablet, effervescent |
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Labeler - Supervalu Inc. (006961411) |